BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
FDA 510(k) clearance K991432 · decided 1999-06-02
Clearance details
- K-number
- K991432
- Device name
- BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
- Applicant
- Biocheck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-26
- Decision date
- 1999-06-02
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product recall (Z-0214-2022) | BioCheck, Inc. | 2021-11-10 |