510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811442Substantially Equivalent

Kwik-Lac Beta-Lactamase Kits

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

K811442 is the FDA 510(k) clearance record for KWIK-LAC BETA-LACTAMASE KITS, cleared for Windsor Laboratories, Inc. on . FDA records list 19 510(k) clearances for Windsor Laboratories, Inc., from to . As of , FDA records show no recalls naming K811442.

Clearance record

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