510(k) K962435 ยท CFR Hexokinase, Glucose
STC AUTO-LYTE URINARY GLUCOSE ASSAY
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Dec 26, 1996 |
| Received | Jun 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962435
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.