510(k) K911801 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
| Applicant | Gds Technology, LLC, Elkhart IN, US |
| Decision | Substantially Equivalent, Jul 1, 1991 |
| Received | Apr 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911801
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.