510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812371Substantially Equivalent

Hemolysin

Dutchland Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812371 is the FDA 510(k) clearance record for HEMOLYSIN, cleared for Dutchland Laboratories, Inc. on . FDA records list 75 510(k) clearances for Dutchland Laboratories, Inc., from to . As of , FDA records show no recalls naming K812371.

Clearance record

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