510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813215Substantially Equivalent

Y-Glutamyltransferase

American Monitor Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813215 is the FDA 510(k) clearance record for Y-GLUTAMYLTRANSFERASE, cleared for American Monitor Corp. on . FDA records list 73 510(k) clearances for American Monitor Corp., from to . As of , FDA records show no recalls naming K813215.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
American Monitor Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No