IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
FDA 510(k) clearance K982100 · decided 1999-12-20
Clearance details
- K-number
- K982100
- Device name
- IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-15
- Decision date
- 1999-12-20
- Days to decision
- 553 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying huma recall (Z-1073-2017) | The Binding Site Group, Ltd. | 2017-01-23 |