IMMULITE THYROGLOBULIN MODEL LKTY
FDA 510(k) clearance K982466 · decided 1999-03-12
Clearance details
- K-number
- K982466
- Device name
- IMMULITE THYROGLOBULIN MODEL LKTY
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-15
- Decision date
- 1999-03-12
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- MSW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMMULITE /IMMULITE 1000 TG recall (Z-1684-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |