510(k) K011169 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
| Applicant | International Enzymes, Inc., Fallbrook CA, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Apr 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011169
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.