Cleared Traditional

VARELISA SSDNA ANTIBODIES, MODEL 14896

K040811 · Pharmacia Deutschland GmbH · Immunology
May 2004
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K040811 is an FDA 510(k) clearance for the VARELISA SSDNA ANTIBODIES, MODEL 14896, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 13, 2004, 45 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 K040811 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2004
Decision Date May 13, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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