Cleared Traditional

VENTANA CD45 PRIMARY ANTIBODY

K940583 · Ventana Medical Systems, Inc. · Immunology
Oct 1997
Decision
1350d
Days
Class 2
Risk

About This 510(k) Submission

K940583 is an FDA 510(k) clearance for the VENTANA CD45 PRIMARY ANTIBODY, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on October 20, 1997, 1350 days after receiving the submission on February 8, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K940583 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1994
Decision Date October 20, 1997
Days to Decision 1350 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEH — Lambda, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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