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510(k) K872891

LACTATE DEHYDROGENASE ISOENZYME 1 by Data Medical Associates, Inc. — Product Code CEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
July 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

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Other clearances for product code CEX

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  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K800129 — CENTRIFICHEM CREATININE (February 13, 1980)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)