Cleared Traditional

TEST FOR HUMAN ALPHA ONE ACID GLYCO-

K831960 · Kent Laboratories, Inc. · Chemistry
Jul 1983
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K831960 is an FDA 510(k) clearance for the TEST FOR HUMAN ALPHA ONE ACID GLYCO-, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 32 days after receiving the submission on June 17, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K831960 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1983
Decision Date July 19, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5420

Similar Devices — LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

All 10
K-ASSAY ALPHA-1 AG
K993441 · Kamiya Biomedical Co. · Nov 1999
N-ASSAY TIA MULTI V-NL
K964299 · Crestat Diagnostics, Inc. · Jul 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257 · Beckman Instruments, Inc. · Mar 1997
AL-ACID GLYCOPROTEIN RID KIT
K922417 · The Binding Site, Ltd. · Aug 1992
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · Reagents Applications, Inc. · Nov 1990
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · Technicon Instruments Corp. · Nov 1988