CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH— 510(k) K954608
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K954608 for CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH, Substantially Equivalent on 1995-12-26. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
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