510(k) K981897 ยท CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Aug 26, 1998 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981897
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.