510(k) K982382 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
COBAS INTEGRA REAGENT CASSETTES
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Sep 28, 1998 |
| Received | Jul 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2007 | Roche Diagnostics Corp. Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic. Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.