BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04— 510(k) K991866
Substantially EquivalentA.P. Total Care, Inc.
FDA 510(k) clearance K991866 for BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04, Substantially Equivalent on 1999-08-02. Applicant: A.P. Total Care, Inc.. Device class: 2.
Clearance details
- Applicant
- A.P. Total Care, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
Recent devices under product code CIG
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