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510(k) K823550

CK-ISOZYME U.V. REAGENT SET by Gelman Sciences, Inc. — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
November 30, 1982
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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  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
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  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884177 — DRUG STANDARD SET (February 17, 1989)

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