510(k) K011126 ยท JIT Calibrator, Secondary
RAICHEM CREATININE URINE STANDARD
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Apr 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011126
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.