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510(k) K760476

REAGENT, LACTATE DEHYDROGENASE by Simmler & Son, Inc. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
August 17, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

Other clearances by Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760475 — REAGENT, CALCIUM DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)

Other clearances for product code CFJ

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  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (September 9, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (January 22, 1998)
  • K973589 — LIQUID LDH-L REAGENT SET (October 8, 1997)
  • K970684 — LACTATE DEHYDROGENASE (LD) (May 7, 1997)
  • K971398 — LD-L REAGENT (May 2, 1997)
  • K964912 — LACTATE DEHYDROGENASE (January 9, 1997)
  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (June 3, 1996)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (August 7, 1995)