BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
FDA 510(k) clearance K961566 · decided 1996-11-18
Clearance details
- K-number
- K961566
- Device name
- BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
- Applicant
- Biocircuits Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-23
- Decision date
- 1996-11-18
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.