510(k) K973649 ยท KHG Whole Blood Hemoglobin Determination
HEMOSITE TEST SYSTEM
| Applicant | Gds Technology, LLC, Elkhart IN, US |
| Decision | Substantially Equivalent, Aug 31, 1998 |
| Received | Sep 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973649
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.