GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02— 510(k) K990981
Substantially EquivalentA.P. Total Care, Inc.
FDA 510(k) clearance K990981 for GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02, Substantially Equivalent on 1999-05-25. Applicant: A.P. Total Care, Inc.. Device class: 2.
Clearance details
- Applicant
- A.P. Total Care, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
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