510(k) K904049 ยท JGZ O-Phthalaldehyde, Urea Nitrogen
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Oct 12, 1990 |
| Received | Sep 4, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904049
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.