FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
FDA 510(k) clearance K063693 · decided 2007-05-11
Clearance details
- K-number
- K063693
- Device name
- FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
- Applicant
- New Bay Bioresearch Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-13
- Decision date
- 2007-05-11
- Days to decision
- 149 days
- Clearance type
- Traditional
- 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 - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal O recall (Z-2108-2011) | Alere North Americal | 2011-04-28 |
| Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal O recall (Z-2109-2011) | Alere North Americal | 2011-04-28 |
| Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Nu recall (Z-2110-2011) | Alere North Americal | 2011-04-28 |
| Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number: 8 recall (Z-2111-2011) | Alere North Americal | 2011-04-28 |