VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696— 510(k) K020758

Clearance details

Applicant

Pharmacia Deutschland GmbH

Product code

Code MID

Device class

Class 2

Regulation

21 CFR 866.5660

Advisory panel

Immunology

Date received

2002-03-07

Decision date

2002-05-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Freiburg, DE

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• K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/177962004-07-02
• K040810 — VARELISA HISTONE ANTIBODIES, MODEL 164962004-05-14
• K040811 — VARELISA SSDNA ANTIBODIES, MODEL 148962004-05-13
• K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 187962004-05-11
• K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 189962004-05-11

• Z-2285-2012 — PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)Class III·Terminated·Phadia US Inc·20120802

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020758.