Cleared Traditional

K940422 - IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
(FDA 510(k) Clearance)

K940422 · The Binding Site, Ltd. · Immunology

May 1994

Decision

128d

Days

Class 2

Risk

K940422 is an FDA 510(k) clearance for the IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on May 27, 1994, 128 days after receiving the submission on January 19, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K940422 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 1994
Decision Date	May 27, 1994
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement