CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)— 510(k) K960800
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K960800 for CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK), Substantially Equivalent on 1996-07-26. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
Recent devices under product code CGN
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