Cleared Traditional

FITC GOAT ANTI-HUMAN LAMBA

K832267 · Gelco Diagnostics, Inc. · Immunology

Oct 1983

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K832267 is an FDA 510(k) clearance for the FITC GOAT ANTI-HUMAN LAMBA, a Lambda, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code DES), submitted by Gelco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983, 123 days after receiving the submission on June 30, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number	K832267 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1983
Decision Date	October 31, 1983
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—