Cleared Traditional

K850588 - SPQ TEST SYSTEM FOR COMPLEMENT C3
(FDA 510(k) Clearance)

K850588 · Applications Lab · Immunology

Mar 1985

Decision

20d

Days

Class 2

Risk

K850588 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR COMPLEMENT C3, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 5, 1985, 20 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	K850588 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 1985
Decision Date	March 05, 1985
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—