Cleared Traditional

K890563 - SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
(FDA 510(k) Clearance)

K890563 · Atlantic Antibodies · Immunology

Mar 1989

Decision

38d

Days

Class 2

Risk

K890563 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR TRF, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on March 3, 1989, 38 days after receiving the submission on January 24, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number	K890563 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1989
Decision Date	March 03, 1989
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—