ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)— 510(k) K860724
Substantially EquivalentTrace Scientific , Ltd.
FDA 510(k) clearance K860724 for ENZYMATIC GLUCOSE REAGENT (HEXOKINASE), Substantially Equivalent on 1986-04-07. Applicant: Trace Scientific , Ltd.. Device class: 2.
Clearance details
- Applicant
- Trace Scientific , Ltd.
- 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
- Clayton, Vic 3168, AU
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