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510(k) K831391

SHOT GUN KIT FOR CK-MB by Serapine Corp. — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1983
Date Received
April 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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