510(k) K891299 ยท DAQ Igg (Fd Fragment Specific), Antigen, Antiserum, Control
MID-LEVEL IGG KIT CAT. NO. 9315
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 22, 1989 |
| Received | Mar 13, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891299
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.