DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX— 510(k) K073488
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K073488 for DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX, Substantially Equivalent on 2008-03-07. Applicant: Diazyme Laboratories. Device class: 1.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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