510(k) K880038 ยท KHG Whole Blood Hemoglobin Determination
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Apr 21, 1988 |
| Received | Jan 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880038
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.