Cleared Traditional

SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B

K891154 · Atlantic Antibodies · Immunology
Mar 1989
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K891154 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on March 16, 1989, 10 days after receiving the submission on March 6, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K891154 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1989
Decision Date March 16, 1989
Days to Decision 10 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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