DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A— 510(k) K032798
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K032798 for DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A, Substantially Equivalent on 2003-10-30. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JHM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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