510(k) K974695 ยท CKB Acid Phosphatase, Naphthyl Phosphate
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 21, 1998 |
| Received | Dec 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974695
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.