Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K833027Substantially Equivalent

Haemophilus/neisseria Identif-Panel

American Micro Scan, Mchenry IL / Traditional, Substantially Equivalent

K833027 is the FDA 510(k) clearance record for HAEMOPHILUS/NEISSERIA IDENTIF-PANEL, cleared for American Micro Scan on . FDA records list 24 510(k) clearances for American Micro Scan, from to . As of , FDA records show no recalls naming K833027.

Clearance record

Decision date
Received
(51 days to decision)
Review panel
Unknown
Applicant
American Micro Scan 803 N. Front St. Suite 3, Mchenry IL
Third party review
No