Atlas FDA

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.