Cleared Traditional

VARELISA HISTONE ANTIBODIES, MODEL 16496

K040810 · Pharmacia Deutschland GmbH · Immunology
May 2004
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K040810 is an FDA 510(k) clearance for the VARELISA HISTONE ANTIBODIES, MODEL 16496, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 14, 2004, 46 days after receiving the submission on March 29, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K040810 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2004
Decision Date May 14, 2004
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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