510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780114Substantially Equivalent

Immunozyme E. Histolytica Antigens

EMD Millipore Corporation, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780114 is the FDA 510(k) clearance record for IMMUNOZYME E. HISTOLYTICA ANTIGENS, cleared for Millipore Corp. on . FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K780114.

Clearance record

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