510(k) K073431 ยท KHE Reagent, Occult Blood
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jan 14, 2008 |
| Received | Dec 6, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8111KCV (30 Test Kit ),
Intended Use: Immunochemical device intended for the qualitative Terminated |
KHE | None listed |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8112KCV (5 Test Kit ),
Intended Use: Immunochemical device intended for the qualit Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.