Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K800867Substantially Equivalent

Dose Calibration Ref. Sources; Barium-13

Amersham Corp., Mchenry IL / Traditional, Substantially Equivalent

K800867 is the FDA 510(k) clearance record for DOSE CALIBRATION REF. SOURCES; BARIUM-13, cleared for Amersham Corp. on . FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K800867.

Clearance record

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