Cleared Traditional

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796

K040449 · Pharmacia Deutschland GmbH · Immunology
May 2004
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K040449 is an FDA 510(k) clearance for the VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 11, 2004, 81 days after receiving the submission on February 20, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K040449 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2004
Decision Date May 11, 2004
Days to Decision 81 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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