510(k) K033612 ยท NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
FACTOR II (PROTHROMBIN) G20210A KIT
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 18, 2003 |
| Received | Nov 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2011 | Roche Diagnostics Operations, Inc. Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN
The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point Terminated |
NPR | None listed |
| Mar 5, 2010 | Roche Molecular Systems, Inc. FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001
Cont.
1 FIIG20210A MD Mix, 1 x 78 uL
2. FIIG20210A R mix, 1 x 78 uL
3. FIIG20210A CT, 1 x 50 uL
5, FIIG20 Terminated |
NPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.