Cleared Traditional

SPQ(TM) ANTIBODY REAGENT SET II FOR C3

K890417 · Atlantic Antibodies · Immunology
Feb 1989
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K890417 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR C3, a Reagent, Complement (Class I — General Controls, product code KTQ), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 17, 1989, 24 days after receiving the submission on January 24, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4100.

Submission Details

510(k) Number K890417 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1989
Decision Date February 17, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KTQ — Reagent, Complement
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.4100