510(k) K032563 ยท JHI Visual, Pregnancy Hcg, Prescription Use
CLINITEST HCG PREGNANCY TEST
| Applicant | Bayer Healthcare, LLC, Medfield MA, US |
| Decision | Substantially Equivalent, Dec 23, 2003 |
| Received | Aug 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2012 | Siemens Healthcare Diagnostics Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105).
For in vitro diagnostic u Terminated |
JHI | None listed |
| Sep 1, 2008 | Siemens Medical Solutions Diagnostics In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro d Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.