TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
FDA 510(k) clearance K991666 · decided 1999-06-30
Clearance details
- K-number
- K991666
- Device name
- TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
- Applicant
- A.P. Total Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-14
- Decision date
- 1999-06-30
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- JMO
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bridgeport, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.