510(k) K972250 ยท JFJ Catalytic Methods, Amylase
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Aug 12, 1997 |
| Received | Jun 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972250
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2008 | Roche Diagnostics Corp. Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250 Terminated |
JFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.