URIC ACID/ALDH— 510(k) K802371
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K802371 for URIC ACID/ALDH, Substantially Equivalent on 1980-10-23. Applicant: Boehringer Mannheim Corp.. Device class: 1.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code CDO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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