510(k) K864544 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
DIABETES RISK DETECTOR
| Applicant | Pearce Clinical Laboratories, Inc., Conroe TX, US |
| Decision | Substantially Equivalent, Jul 27, 1987 |
| Received | Nov 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864544
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.