Cleared Traditional

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC

K801909 · J.T. Baker Chemical Co. · Immunology
Sep 1980
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K801909 is an FDA 510(k) clearance for the LSA 290 ASSAY REAGENTS/NEPHELOMETRIC, a Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code DEX), submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 46 days after receiving the submission on August 11, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K801909 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1980
Decision Date September 26, 1980
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

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