DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137— 510(k) K010206
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K010206 for DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137, Substantially Equivalent on 2001-03-16. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code KHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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