IMMULITE(R) TBG
FDA 510(k) clearance K950072 · decided 1995-04-03
Clearance details
- K-number
- K950072
- Device name
- IMMULITE(R) TBG
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-09
- Decision date
- 1995-04-03
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Bi recall (Z-1629-2015) | Siemens Healthcare Diagnostics, Inc. | 2015-05-19 |