Company
Alere North Americal
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHE | Reagent, Occult Blood | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K063693 |
| 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 | K063693 |
| 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 | K063693 |
| 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 | K063693 |
| 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 | K073431 |
| 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 | K073431 |