510(k) K063693 ยท KHE Reagent, Occult Blood
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
| Applicant | New Bay Bioresearch Co. , Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 11, 2007 |
| Received | Dec 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test)
Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8114KCV (25 Test Kit ),
Intended Use: Immunochemical device Terminated |
KHE | None listed |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test)
Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8115KCV (25 Test Kit ),
Intended Use: Immunochemical device i Terminated |
KHE | None listed |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory)
Product Part Number:
8116KCV
Intended Use: Immunochemical device intended for the qualitative detection if fecal occult bloo Terminated |
KHE | None listed |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory)
Product Part Number:
8117KCV
Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in hu Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.