510(k) K873363 ยท KNK Acid, Uric, Uricase (Colorimetric)
URIC ACID PAP
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 19, 1987 |
| Received | Aug 21, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Uric Acid plus ver.2
In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus system Terminated |
KNK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.