510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K781659Substantially Equivalent

Assay System, Gammaflo, Automated

E. R. Squibb & Sons, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781659 is the FDA 510(k) clearance record for ASSAY SYSTEM, GAMMAFLO, AUTOMATED, cleared for E. R. Squibb & Sons, Inc. on . FDA records list 32 510(k) clearances for E. R. Squibb & Sons, Inc., from to . As of , FDA records show no recalls naming K781659.

Clearance record

Decision date
Received
(26 days to decision)
Review panel
Unknown
Applicant
E. R. Squibb & Sons, Inc. 40 W 57th St., New York NY
Third party review
No