CRITIC-ARS
FDA 510(k) clearance K844709 · decided 1985-01-08
Clearance details
- K-number
- K844709
- Device name
- CRITIC-ARS
- Applicant
- Dimension Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1984-12-03
- Decision date
- 1985-01-08
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Charles, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.