Glucochek Pocketlab II Blood Glucose System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K971653 FDA 510(k)
- FDA Product Code
- CGA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Glucochek Pocketlab II Blood Glucose System is an in vitro diagnostic device designed for the quantitative measurement of glucose in capillary whole blood. It is intended for use by patients or healthcare professionals to monitor blood glucose levels.
The device is supplied as a system and is regulated under FDA 510(k) clearance with product code CGA. It is manufactured by Clinical Diagnostics, Inc. and is classified as a Class II device for clinical chemistry applications.
Frequently asked questions
What is the Glucochek Pocketlab II Blood Glucose System used for?
The Glucochek Pocketlab II Blood Glucose System is an in vitro diagnostic device designed for the quantitative measurement of glucose in capillary whole blood. It is intended for use by patients or healthcare professionals to monitor blood glucose levels.
How is the Glucochek Pocketlab II Blood Glucose System supplied?
The device is supplied as a complete system. It is manufactured by Clinical Diagnostics, Inc. and is classified as a Class II device for clinical chemistry applications, regulated under FDA 510(k) clearance with product code CGA.
Is the Glucochek Pocketlab II Blood Glucose System single-use or reusable?
The device description does not specify whether the Glucochek Pocketlab II Blood Glucose System is single-use or reusable. For specific usage instructions regarding reusability, please refer to the manufacturer's documentation or contact Clinical Diagnostics, Inc. directly.
What is the regulatory status of the Glucochek Pocketlab II Blood Glucose System?
The Glucochek Pocketlab II Blood Glucose System is regulated under FDA 510(k) clearance with product code CGA. It was received by the FDA on May 6, 1997, and received a decision on January 2, 1998, classified as substantially equivalent under decision code SESE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (K971653) — FDA 510(k ..., K971653 - Glucochek Pocketlab Ii Blood Glucose System, Clinical Diagnostics, Inc. FDA 510 (k) Products (1977-1998), GLUCOCHEK POCKETLAB by CLINICAL DIAGNOSTICS, INC. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971653 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clinical Diagnostics, Inc.
Sources (1)
- FDA 510(k) K971653 24 fields · synced Sep 26, 2026