510(k) K971177 ยท CDD Radioassay, Vitamin B12
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, May 16, 1997 |
| Received | Mar 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 Vitamin B12 Terminated |
CDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.