Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K840128Substantially Equivalent

Counter Model S880

Coulter Electronics, Inc., Mchenry IL / Traditional, Substantially Equivalent

K840128 is the FDA 510(k) clearance record for COUNTER MODEL S880, cleared for Coulter Electronics, Inc. on . FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K840128.

Clearance record

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