Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K771154Substantially Equivalent

Cpk-Int Test

Hycel, Inc., Mchenry IL / Traditional, Substantially Equivalent

K771154 is the FDA 510(k) clearance record for CPK-INT TEST, cleared for Hycel, Inc. on . FDA records list 19 510(k) clearances for Hycel, Inc., from to . As of , FDA records show no recalls naming K771154.

Clearance record

Decision date
Received
(23 days to decision)
Review panel
Unknown
Applicant
Hycel, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No