Cleared Traditional

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

K890561 · Atlantic Antibodies · Immunology
Feb 1989
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K890561 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR IGM, a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFQ), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 23, 1989, 30 days after receiving the submission on January 24, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K890561 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1989
Decision Date February 23, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CFQ — Radioimmunoassay, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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