DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE— 510(k) K062316
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K062316 for DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2006-09-06. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1065
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- P.O. Box 6101, Newark, DE, US
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