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510(k) K771605

CREATINE KINASE ISOENZYME SUBSTRATE SET by Pfizer Pharmaceuticals — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Pfizer Pharmaceuticals

  • K885321 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (March 22, 1989)
  • K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (March 31, 1981)
  • K802408 — E-VAC BLOOD CULTURE SYSTEM (October 23, 1980)
  • K770801 — MICROBIO. PROD. FLUORESCENT ANTIBODY (May 25, 1977)
  • K770425 — NEEDLES, STERILE, AIRWAY (April 15, 1977)

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  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
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  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
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  • K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND (January 17, 2003)