Cleared Traditional

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.

K801662 · J.T. Baker Chemical Co. · Immunology
Sep 1980
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K801662 is an FDA 510(k) clearance for the J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH., a Lambda, Peroxidase, Antigen, Antiserum, Control (Class II — Special Controls, product code DEP), submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 57 days after receiving the submission on July 21, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K801662 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1980
Decision Date September 16, 1980
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEP — Lambda, Peroxidase, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550