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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K833214Substantially Equivalent

Dextrose

Neogen Culture Media, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833214 is the FDA 510(k) clearance record for DEXTROSE, cleared for Acumedia Manufacturers, Inc. on . FDA records list 177 510(k) clearances for Neogen Culture Media, from to . As of , FDA records show no recalls naming K833214.

Clearance record

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