RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER— 510(k) K023784
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K023784 for RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER, Substantially Equivalent on 2002-12-24. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Columbia, MD, US
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More clearances from Hemagen Diagnostics, Inc.
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