Cleared Traditional

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

K850586 · Applications Lab · Immunology
Mar 1985
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K850586 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 14, 1985, 29 days after receiving the submission on February 13, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K850586 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1985
Decision Date March 14, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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