510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830957Substantially Equivalent

Flow-Pac Triglyceride Reagent

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

K830957 is the FDA 510(k) clearance record for FLOW-PAC TRIGLYCERIDE REAGENT, cleared for Amresco, Inc. on . FDA records list 39 510(k) clearances for Amresco, Inc., from to . As of , FDA records show no recalls naming K830957.

Clearance record

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