510(k) K112101 ยท JHI Visual, Pregnancy Hcg, Prescription Use
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
| Applicant | Polymed Therapeutics, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Jul 17, 2012 |
| Received | Jul 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2016 | Ekla Corporation NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS
Product Usage:
pregnancy test Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.