Cleared Traditional

SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN

K850603 · Applications Lab · Immunology
Mar 1985
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K850603 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 5, 1985, 18 days after receiving the submission on February 15, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.

Submission Details

510(k) Number K850603 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1985
Decision Date March 05, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5620

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