Cleared Traditional

N-ASSAY TIA C1-INACTIVATOR TEST KIT

K965024 · Crestat Diagnostics, Inc. · Immunology

Jul 1997

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K965024 is an FDA 510(k) clearance for the N-ASSAY TIA C1-INACTIVATOR TEST KIT, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on July 14, 1997, 209 days after receiving the submission on December 17, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K965024 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1996
Decision Date	July 14, 1997
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5250