510(k) K990664 ยท LLH Reagents, Clostridium Difficile Toxin
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
| Applicant | Intracel Corp., Rockville MD, US |
| Decision | Substantially Equivalent, Mar 31, 1999 |
| Received | Mar 1, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K990664
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.