DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)— 510(k) K072270
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K072270 for DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON), Substantially Equivalent on 2008-02-01. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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