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510(k) K900667

AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 by American Research Products Co. — Product Code CFJ

K900667 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711". The FDA issued a decision of Substantially Equivalent on April 19, 1990. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1990
Date Received
February 13, 1990
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 American Research Products Co.

  • K942984 — BUN REAGENT (March 1, 1995)
  • K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN (July 19, 1990)
  • K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726 (May 31, 1990)
  • K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (May 31, 1990)
  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)
  • K901702 — NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (April 25, 1990)
  • K900666 — AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (April 19, 1990)
  • K900571 — AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (April 16, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)
  • K900977 — AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 (April 11, 1990)

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