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
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K821060Substantially Equivalent

Fluoro-Cep

Zeus Scientific LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821060 is the FDA 510(k) clearance record for FLUORO-CEP, cleared for Zeus Scientific, Inc. on . FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K821060.

Clearance record

Decision date
Received
(68 days to decision)
Review panel
Unknown
Applicant
Zeus Scientific, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No