DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022— 510(k) K070853
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K070853 for DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022, Substantially Equivalent on 2007-06-13. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3040
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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