DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A— 510(k) K060619
Substantially EquivalentDiazyme Laboratories
FDA 510(k) clearance K060619 for DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A, Substantially Equivalent on 2006-07-21. Applicant: Diazyme Laboratories. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories
- Product code
- Code KHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.