510(k) K003120 ยท LCP Assay, Glycosylated Hemoglobin
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 18, 2000 |
| Received | Oct 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2005 | Roche Diagnostics Corp. Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.