Medical Device Manufacturer · US , Walker , MI

American Research Products Co.

56 submissions · 56 cleared · Since 1981
56
Total
56
Cleared
0
Denied

American Research Products Co. — FDA 510(k) Submissions

American Research Products Co. has submitted 56 FDA 510(k) premarket notifications since 1981, of which 56 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Diazo Colorimetry, Bilirubin, Electrode, Ion Specific, Sodium, Phosphomolybdate (colorimetric), Inorganic Phosphorus, Glucose Oxidase, Glucose, Urease And Glutamic Dehydrogenase, Urea Nitrogen . Use the specialty filter in the sidebar to narrow results.

56 devices
1–25 of 56
BUN REAGENT
K942984 · CDQ Urease And Glutamic... · Chemistry
Mar 1995 254d
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527 · CEK Biuret (colorimetric),... · Chemistry
Jul 1990 108d
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · JMO Ferrozine (colorimetric)... · Chemistry
May 1990 30d
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
K901964 · CEO Phosphomolybdate... · Chemistry
May 1990 30d
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · CHI Lipase-esterase,... · Chemistry
May 1990 70d
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · CKA Nadh Oxidation/nad... · Chemistry
Apr 1990 13d
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
K900666 · CGX Alkaline Picrate,... · Chemistry
Apr 1990 65d
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667 · CFJ Nad Reduction/nadh... · Chemistry
Apr 1990 65d
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
K900571 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Apr 1990 68d
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · CDQ Urease And Glutamic... · Chemistry
Apr 1990 72d
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · CEO Phosphomolybdate... · Chemistry
Apr 1990 39d
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250 · CJE Nitrophenylphosphate,... · Chemistry
Mar 1990 43d
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · JFL Ph Rate Measurement,... · Chemistry
Mar 1990 30d
AMRESCO CREATININE REAGENT #4316100
K896686 · CGX Alkaline Picrate,... · Chemistry
Feb 1990 72d
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · CFR Hexokinase, Glucose · Chemistry
Nov 1989 29d
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
K894310 · CDT Lipase... · Chemistry
Sep 1989 76d
AMRESCO PRODUCT NUMBER 7426
K891923 · CFR Hexokinase, Glucose · Chemistry
Jun 1989 85d
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
K891912 · CDQ Urease And Glutamic... · Chemistry
Jun 1989 84d
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · CHH Enzymatic... · Chemistry
Jun 1989 81d
AMRESCO URIC ACID REAGENTS #7628
K892395 · KNK Acid, Uric, Uricase... · Chemistry
May 1989 47d
URIC ACID KIT, CODES 4825400 AND 4825050
K890319 · KNK Acid, Uric, Uricase... · Chemistry
Apr 1989 79d
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262 · CGA Glucose Oxidase, Glucose · Chemistry
Feb 1989 247d
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · CGA Glucose Oxidase, Glucose · Chemistry
Jan 1989 41d
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056 · JJC Analyzer, Chemistry... · Chemistry
Nov 1988 249d
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · JIW Calibrator, Surrogate · Chemistry
Jun 1988 111d
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