LKL · Class I · 21 CFR 866.5420

FDA Product Code LKL: Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., Unipath , Ltd. and Technicon Instruments Corp..

11
Total
11
Cleared
87d
Avg days
1983
Since

FDA 510(k) Cleared Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control Devices (Product Code LKL)

11 devices
1–11 of 11
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AG
K993441
Kamiya Biomedical Co.
Immunology · 43d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964299
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Mar 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257
Beckman Instruments, Inc.
Immunology · 150d
Cleared Aug 20, 1992
AL-ACID GLYCOPROTEIN RID KIT
K922417
The Binding Site, Ltd.
Immunology · 91d
Cleared Nov 13, 1990
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175
Reagents Applications, Inc.
Immunology · 63d
Cleared Nov 04, 1988
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217
Technicon Instruments Corp.
Immunology · 23d
Cleared Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868
Unipath , Ltd.
Immunology · 57d
Cleared Jul 19, 1983
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960
Kent Laboratories, Inc.
Chemistry · 32d

About Product Code LKL - Regulatory Context