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510(k) K033155

BIOCENTREX CARDIAC PANEL by Biocentrex — Product Code MYT

K033155 is an FDA 510(k) premarket notification submitted by Biocentrex for the device "BIOCENTREX CARDIAC PANEL". The FDA issued a decision of Substantially Equivalent on January 12, 2004. The device falls under product code MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 12, 2004
Date Received: September 30, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Biosensor, Immunoassay, Cpk Or Isoenzymes
Device Class: Class II
Regulation Number: 862.1215
Review Panel: CH
Submission Type