Cleared Traditional

N-ASSAY TIA MULTI V-NL

K964301 · Crestat Diagnostics, Inc. · Immunology
Jul 1997
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K964301 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI V-NL, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), 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 866.5460.

Submission Details

510(k) Number K964301 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

Device Classification

Product Code DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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