CRITIC C LEVEL I & II— 510(k) K853943
Substantially EquivalentDimension Diagnostics
FDA 510(k) clearance K853943 for CRITIC C LEVEL I & II, Substantially Equivalent on 1985-12-23. Applicant: Dimension Diagnostics. Device class: 1.
Clearance details
- Applicant
- Dimension Diagnostics
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Peters, MO, US
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More clearances from Dimension Diagnostics
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