510(k) K003306 ยท LLH Reagents, Clostridium Difficile Toxin
C. DIFFICILE TOX A/B II
| Applicant | Techlab, Inc., Blacksburg VA, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | Oct 20, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003306
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.