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510(k) K033155

BIOCENTREX CARDIAC PANEL by Biocentrex — Product Code MYT

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

Other clearances for product code MYT

  • K051433 — I-STAT CREATINE KINASE MB (CK-MB) (December 15, 2005)
  • K984433 — QUANTECH CK-MB ASSAY (November 1, 1999)