# K971653: Glucochek Pocketlab II Blood Glucose System

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Diagnostics, Inc.
- Decided: Jan 2, 1998 after 241 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Glucochek Pocketlab II Blood Glucose System is intended for the quantitative measurement of glucose in capillary whole blood.

Source page: https://510kreport.com/device/K971653
Methodology: https://510kreport.com/methodology