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510(k) K961412

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO by Bayer Corp. — Product Code JHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1996
Date Received
April 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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