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
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K864611Substantially Equivalent

Immuno-Sure

Coulter Electronics, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864611 is the FDA 510(k) clearance record for IMMUNO-SURE, cleared for Coulter Electronics, Inc. on . FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K864611.

Clearance record

Decision date
Received
(72 days to decision)
Review panel
Unknown
Applicant
Coulter Electronics, Inc. 440 W. 20 St., Hialeah FL
Third party review
No