DIAGNOSTIC KIT FREE T3 AND FREE T4
FDA 510(k) clearance K870268 · decided 1987-09-14
Clearance details
- K-number
- K870268
- Device name
- DIAGNOSTIC KIT FREE T3 AND FREE T4
- Applicant
- Sclavo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-23
- Decision date
- 1987-09-14
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- CEC
- Device class
- 2
- Regulation number
- 862.1695
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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| LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 (K121951) | DiaSorin, Inc. | 2013-04-04 |
Recalls involving this device
No recalls on record reference this clearance.