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510(k) K872041

COULTER DART CK-MB ISOENZYME REAGENT SYSTEM by Coulter Electronics, Inc. — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
May 27, 1987
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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  • K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (February 16, 1990)
  • K881168 — CREATINE KINASE (CK) ISOENZYME MB (November 10, 1988)
  • K874284 — SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (January 21, 1988)
  • K872598 — MICROMI-CK(TM) (August 3, 1987)