DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS— 510(k) K102638
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K102638 for DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS, Substantially Equivalent on 2010-11-30. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Poway, CA, US
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