Cleared Traditional

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

K041043 · Pharmacia Deutschland GmbH · Immunology
Jul 2004
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K041043 is an FDA 510(k) clearance for the VARELISA PR3 ANCA, MODEL NUMBER 17748/17796, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Pharmacia Deutschland GmbH (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on July 2, 2004, 71 days after receiving the submission on April 22, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K041043 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2004
Decision Date July 02, 2004
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 73
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
K243776 · Zeus Scientific · May 2025
EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern
K172582 · Euroimmun Us, Inc. · May 2018
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
K172461 · Aesku.Diagnostics GmbH & Co. KG · Mar 2018
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
K173792 · Phadia AB · Mar 2018
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · Inova Diagnostics, Inc. · Feb 2017
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · Phadia US, Inc. · Oct 2014