CK(OPTIMIZED) REAGENT
FDA 510(k) clearance K854501 · decided 1985-12-04
Clearance details
- K-number
- K854501
- Device name
- CK(OPTIMIZED) REAGENT
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-12
- Decision date
- 1985-12-04
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.