510(k) K101203 ยท DCF Albumin, Antigen, Antiserum, Control
TINA-QUANT ALBUMIN GEN 2
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 10, 2010 |
| Received | Apr 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | Roche Diagnostics Corporation COBAS INTEGRA 400 plus analyzer used in the following assays:
a)Tina-quant Apolipoprotein A-1 ver.2
Catalog Number: 03032566122
b)Tina-quant Albumin Gen.2
Catalog Number 04469658190
c)Creatinine p Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.