510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771084Substantially Equivalent

Dynazyme II Y-Gt

J.T. Baker Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771084 is the FDA 510(k) clearance record for DYNAZYME II Y-GT, cleared for J.T. Baker Chemical Co. on . FDA records list 54 510(k) clearances for J.T. Baker Chemical Co., from to . As of , FDA records show no recalls naming K771084.

Clearance record

Decision date
Received
(49 days to decision)
Review panel
Unknown
Applicant
J.T. Baker Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No