510(k) K012319 ยท DIF Drug Mixture Control Materials
RANDOX HUMAN ASSSAYED DRUG CONTROL
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Aug 24, 2001 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012319
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.