URIC ACID (TPTZ) COLORINMETRIC— 510(k) K810088
Substantially EquivalentBio-Analytics Laboratories, Inc.
FDA 510(k) clearance K810088 for URIC ACID (TPTZ) COLORINMETRIC, Substantially Equivalent on 1981-01-28. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Bio-Analytics Laboratories, Inc.
- Product code
- Code CDH
- 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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