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American Research Products Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K942984BUN REAGENTMarch 1, 1995
K901527BIURET (COLORMETRIC), TOTAL PROTEINJuly 19, 1990
K901960IRON REAGENTS PRODUCT CODES 7725 AND 7726May 31, 1990
K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463May 31, 1990
K900827COLORIMETRIC CHLORIDE PRODUCT #4314125May 2, 1990
K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522April 25, 1990
K900667AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711April 19, 1990
K900666AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791April 19, 1990
K900571AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)April 16, 1990
K900977AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500April 11, 1990
K900394AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583April 11, 1990
K900420BICARBONATE REAGENTS PRODUCT #7713 & #7714March 1, 1990
K900250AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781March 1, 1990
K896686AMRESCO CREATININE REAGENT #4316100February 8, 1990
K896028GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600November 14, 1989
K894310AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)September 28, 1989
K891923AMRESCO PRODUCT NUMBER 7426June 20, 1989
K891912AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123June 19, 1989
K891922AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325June 16, 1989
K892395AMRESCO URIC ACID REAGENTS #7628May 24, 1989