URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM— 510(k) K812641
Substantially EquivalentReagents Applications, Inc.
FDA 510(k) clearance K812641 for URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM, Substantially Equivalent on 1981-10-02. Applicant: Reagents Applications, Inc.. Device class: 1.
Clearance details
- Applicant
- Reagents Applications, 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
- Mchenry, IL, US
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