Profile: Ok Biotech Co., Ltd. manufactures glucose meters. We supply glucose meters that include Okmeter glucose meter, match glucose meter, link blood glucose meter and direct blood glucose meter. Our glucose meter has no coding meter and offers alternative site testing and provides accurate results in six seconds. It features PC download, and has test memory with date and time features.
FDA Registration Number: 3005862821
US Agent: Shu-chen Cheng / Roc Chinese-european Industrial Research Society
Phone: +1-(614)-588-8168 E-Mail:
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• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. |
• Blood Collection Lancet (FDA Code: FMK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Blood Glucose Meters |
• Blood glucose testing |
• Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN / 868.6175) A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation. |
• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345) A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. |
• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345) |