510(k) K971653 ยท CGA Glucose Oxidase, Glucose
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
| Applicant | Clinical Diagnostics, Inc., Chester SC, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | May 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971653
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.