510(k) K011057 ยท PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Apr 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011057
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.