INNOVACON HCG UKTRA TEST DEVICE
FDA 510(k) clearance K062361 · decided 2006-10-23
Clearance details
- K-number
- K062361
- Device name
- INNOVACON HCG UKTRA TEST DEVICE
- Applicant
- Innovacon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-14
- Decision date
- 2006-10-23
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urin recall (Z-1587-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy T recall (Z-1606-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 recall (Z-1401-2013) | Alere San Diego, Inc. | 2013-05-25 |
| Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: recall (Z-1118-2008) | Innovacon Inc | 2008-05-06 |