CRITIC-ARS— 510(k) K844709
Substantially EquivalentDimension Diagnostics
FDA 510(k) clearance K844709 for CRITIC-ARS, Substantially Equivalent on 1985-01-08. Applicant: Dimension Diagnostics. Device class: 2.
Clearance details
- Applicant
- Dimension Diagnostics
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Charles, MO, US
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More clearances from Dimension Diagnostics
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