Cleared Traditional

K964299 - N-ASSAY TIA MULTI V-NL
(FDA 510(k) Clearance)

K964299 · Crestat Diagnostics, Inc. · Immunology

Jul 1997

Decision

258d

Days

Class 1

Risk

K964299 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI V-NL, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Crestat Diagnostics, Inc. (Murrieta, US). The FDA issued a Cleared decision on July 14, 1997, 258 days after receiving the submission on October 29, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number	K964299 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 1996
Decision Date	July 14, 1997
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement