510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812123Substantially Equivalent

Cytomegelisa Test Kit

M.A. Bioproducts, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812123 is the FDA 510(k) clearance record for CYTOMEGELISA TEST KIT, cleared for M.A. Bioproducts on . FDA records list 12 510(k) clearances for M.A. Bioproducts, from to . As of , FDA records show no recalls naming K812123.

Clearance record

Decision date
Received
(58 days to decision)
Review panel
Unknown
Applicant
M.A. Bioproducts 803 N. Front St. Suite 3, Mchenry IL
Third party review
No