DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,— 510(k) K102432
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K102432 for DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,, Substantially Equivalent on 2011-01-14. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code MRG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1825
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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