DOCUMENT CK ISOENZYMES CONTROL
FDA 510(k) clearance K915792 · decided 1992-02-06
Clearance details
- K-number
- K915792
- Device name
- DOCUMENT CK ISOENZYMES CONTROL
- Applicant
- Casco Standards
- Decision
- Substantially Equivalent
- Date received
- 1991-12-24
- Decision date
- 1992-02-06
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- CDP
- Device class
- 2
- Regulation number
- 862.1710
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Yarmouth, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.