FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
FDA 510(k) clearance K073431 · decided 2008-01-14
Clearance details
- K-number
- K073431
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-06
- Decision date
- 2008-01-14
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test P recall (Z-2106-2011) | Alere North Americal | 2011-04-28 |
| Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette recall (Z-2107-2011) | Alere North Americal | 2011-04-28 |