510(k) K943705 ยท CGN Acid, Folic, Radioimmunoassay
FOLIC ACID
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 31, 1994 |
| Received | Aug 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2013 | Siemens Healthcare Diagnostics IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyz Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.