CANTROL CK/MB CONTROL
FDA 510(k) clearance K855006 · decided 1986-01-17
Clearance details
- K-number
- K855006
- Device name
- CANTROL CK/MB CONTROL
- Applicant
- Canyon Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-13
- Decision date
- 1986-01-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JJT
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.