Cleared Traditional

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

K850590 · Applications Lab · Immunology
Mar 1985
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K850590 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), 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 866.5270.

Submission Details

510(k) Number K850590 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 DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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