URIC ACID (URICASE) REAGENT, UNIVERSAL— 510(k) K912028
Substantially EquivalentEnzyme Technology, Inc.
FDA 510(k) clearance K912028 for URIC ACID (URICASE) REAGENT, UNIVERSAL, Substantially Equivalent on 1991-12-18. Applicant: Enzyme Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Enzyme Technology, Inc.
- Product code
- Code KNK
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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