Cleared Traditional

VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596

K020752 · Pharmacia Deutschland GmbH · Immunology
May 2002
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K020752 is an FDA 510(k) clearance for the VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 2, 2002, 56 days after receiving the submission on March 7, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K020752 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2002
Decision Date May 02, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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