GLUCOSE (HEXOKINASE) KIT— 510(k) K953210
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K953210 for GLUCOSE (HEXOKINASE) KIT, Substantially Equivalent on 1996-10-25. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, 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
- Crumlin, IE
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