510(k) K991927 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
MEDI-TEST COMBI 11
| Applicant | Macherey-Nagel-Duren, Bethesda MD, US |
| Decision | Substantially Equivalent, Sep 17, 1999 |
| Received | Jun 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991927
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2024 | Macherey Nagel Gmbh & Co. Kg Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique. Open, Classified |
JIL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.