Cleared Traditional

SPQ TEST SYSTEM FOR COMPLEMENT C4

K850585 · Applications Lab · Immunology
Mar 1985
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K850585 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR COMPLEMENT C4, a Complement C4, Antigen, Antiserum, Control (Class II — Special Controls, product code DBI), submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 1, 1985, 16 days after receiving the submission on February 13, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K850585 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1985
Decision Date March 01, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DBI — Complement C4, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240