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510(k) K894310

AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) by American Research Products Co. — Product Code CDT

K894310 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
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)
  • K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (May 31, 1990)
  • K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726 (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)
  • K900667 — AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (April 19, 1990)
  • K900571 — AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (April 16, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)

Other clearances for product code CDT

  • K150819 — Triglycerides (August 6, 2015)
  • K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (November 22, 2013)
  • K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES (May 31, 2013)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (January 18, 2005)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K010871 — TGL FLEX REAGENT CARTRIDGE (July 9, 2001)

FDA data resources