Cleared Traditional

K040450 - VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
(FDA 510(k) Clearance)

K040450 · Pharmacia Deutschland GmbH · Immunology

May 2004

Decision

81d

Days

Class 2

Risk

K040450 is an FDA 510(k) clearance for the VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996, 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	K040450 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