DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR— 510(k) K061296
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K061296 for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR, Substantially Equivalent on 2006-06-13. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
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