510(k) K011550 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG STAT PAK ULTRA-FAST
| Applicant | Chembio Diagnostic Systems, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 14, 2001 |
| Received | May 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011550
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.