Cleared Traditional

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

K873868 · Unipath , Ltd. · Immunology
Oct 1987
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K873868 is an FDA 510(k) clearance for the ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID), a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on October 20, 1987, 57 days after receiving the submission on August 24, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K873868 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1987
Decision Date October 20, 1987
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
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