510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K770605Substantially Equivalent

Tubes, Hydrolysis, Calibrated

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

K770605 is the FDA 510(k) clearance record for TUBES, HYDROLYSIS, CALIBRATED, cleared for Organon, Inc. on . FDA records list 42 510(k) clearances for Organon, Inc., from to . As of , FDA records show no recalls naming K770605.

Clearance record

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