IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
FDA 510(k) clearance K991094 · decided 1999-05-13
Clearance details
- K-number
- K991094
- Device name
- IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-01
- Decision date
- 1999-05-13
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- 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 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid recall (Z-1886-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-05-23 |
| IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid recall (Z-1887-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-05-23 |