Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K827712Substantially Equivalent

Light Pen Accessory for Use with Fetascan 800 Series

Cranston Medical Laboratory, Walker MI / Traditional, Substantially Equivalent

K827712 is the FDA 510(k) clearance record for LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES, cleared for Cranston Medical Laboratory on . FDA records list one 510(k) clearance for Cranston Medical Laboratory. As of , FDA records show no recalls naming K827712.

Clearance record

Decision date
Received
(55 days to decision)
Review panel
Unknown
Applicant
Cranston Medical Laboratory 4221 Richmond Rd., NW, Walker MI
Third party review
No