Cleared Traditional

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)

K951639 · Incstar Corp. · Immunology
Oct 1995
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K951639 is an FDA 510(k) clearance for the COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE), a Complement C9, Antigen, Antiserum, Control (Class II — Special Controls, product code DAE), submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on October 13, 1995, 186 days after receiving the submission on April 10, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K951639 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1995
Decision Date October 13, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DAE — Complement C9, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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