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510(k) K760476

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

K760476 is an FDA 510(k) premarket notification submitted by Simmler & Son, Inc. for the device "REAGENT, LACTATE DEHYDROGENASE". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Simmler & Son, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760477 — REAGENTS-4 FOR URIC ACID DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)

Other clearances for product code CFJ

  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, A (October 2, 2013)
  • 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)

FDA data resources