510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K842501Substantially Equivalent

Tss/fik

Zarcon Corp., Berkeley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842501 is the FDA 510(k) clearance record for TSS/FIK, cleared for Zarcon Corp. on . FDA records list one 510(k) clearance for Zarcon Corp. As of , FDA records show no recalls naming K842501.

Clearance record

Decision date
Received
(259 days to decision)
Review panel
Unknown
Applicant
Zarcon Corp. P.O. Box 428, Berkeley CA
Third party review
No