FDA 510(k) Applications for Medical Device:
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K091859 AESKU.DIAGNOSTICS MIKROFORUM RING 2
WENDELSHEIM, RHEINLAND D-55234
K091860 AESKU.DIAGNOSTICS MIKROFORUM RING 2
WENDELSHEIM, RHEINLAND D-55234
K172461 Aesku.Diagnostics GmbH & Co. KG Mikro-Forum-Ring 2
Wendelsheim 55234
K974701 AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451
WINDHAM NH 03087
K974702 AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451
WINDHAM NH 03087
K100917 BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25
MARNE LA VALLEE CEDEX 2 77435
K053012 BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25
MARNE LA VALLEE CEDEX 2 77435
K070458 BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25
MARNE LA VALLEE CEDEX 2 77435
K002215 COGENT DIAGNOTICS LTD. BUSH LOAN
MIDLOTHIAN EH26 0PL EH26 OPL
K990796 COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK
MIDLOTHIAN, SCOTLAND EH26 OPL
K983390 COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR.
COLUMBIA MD 21045
K983740 COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR.
COLUMBIA MD 21045
K953587 ELIAS U.S.A., INC. 373 280TH ST.
OSCEOLA WI 54020
K953586 ELIAS U.S.A., INC. 373 280TH ST.
OSCEOLA WI 54020
K971689 EURO-DIAGNOSTICA AB 155 CIDER MILL RD.
RINGOES NJ 08551
K971690 EURO-DIAGNOSTICA AB 155 CIDER MILL RD.
RINGOES NJ 08551
K051455 EURODIAGNOSTICA 1306 BAILES LANE, SUITE F
FREDERICK MD 21701
K051458 EURODIAGNOSTICA 1306 BAILES LANE, SUITE F
FREDERICK MD 21701
K083850 EUROIMMUN US INC 95 WASHINGTON ST
MORRISTOWN NJ 07960
K082130 EUROIMMUN US INC 95 WASHINGTON ST
MORRISTOWN NJ 07960
K051489 EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY
BOONTON TWP NJ 07005
K060700 EUROIMMUN US LLC TEK CAMPUS OF MORRIS COUNTY
BOONTON TWP NJ 07005
K172582 Euroimmun US, Inc. 1 Bloomfield Avenue
Mountain Lakes NJ 07046
K973823 HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD.
WALTLHAM MA 02154
K973822 HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD.
WALTLHAM MA 02154
K973824 HEMAGEN DIAGNOSTICS, INC. 34-40 BEAR HILL RD.
WALTLHAM MA 02154
K982898 IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR.
BUFFALO NY 14228
K092601 IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR.
BUFFALO NY 14228-2120
K092599 IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR.
BUFFALO NY 14228
K092600 IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR.
BUFFALO NY 14228-2120
K974463 IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD.
DALLAS TX 75234
K974478 IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD.
DALLAS TX 75234
K013285 IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD.
DALLAS TX 75234
K013283 IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD.
DALLAS TX 75234
K961765 IMMUNO PROBE, INC. 1306F BAILES LN.
FREDERICK MD 21701
K961764 IMMUNO PROBE, INC. 1306F BAILES LN.
FREDERICK MD 21701
K961340 INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST.
SAN DIEGO CA 92121
K161258 INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD
SAN DIEGO CA 92131
K112545 INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD.
SAN DIEGO CA 92131-1638
K955022 INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST.
SAN DIEGO CA 92121
K981330 INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD.
SAN DIEGO CA 92131
K955021 INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST.
SAN DIEGO CA 92121
K981328 INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD.
SAN DIEGO CA 92131
K050715 INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD.
SAN DIEGO CA 92131-1638
K173792 Phadia AB Rapsgatan 7P
Uppsala SE 754 50
K140225 PHADIA US INC. MUNZINGER STRASSE 7
FREIBURG IM BREISGAU 79111
K041043 PHARMACIA DEUTSCHLAND GMBH MUNZINGER STRASSE 7
FREIBURG 79111
K040586 RHIGENE, INC. 12061 TEJON ST.
WESTMINSTER CO 80234
K040711 RHIGENE, INC. 12061 TEJON ST.
WESTMINSTER CO 80234
K954105 SCIMEDX CORP. 400 FORD RD.
DENVILLE NJ 07834
K954062 SCIMEDX CORP. 400 FORD RD.
DENVILLE NJ 07834
K962360 SCIMEDX CORP. 400 FORD RD.
DENVILLE NJ 07834
K010289 SCIMEDX CORP. 400 FORD RD.
DENVILLE NJ 07834
K010287 SCIMEDX CORP. 400 FORD RD.
DENVILLE NJ 07834
K041040 SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7
FREIBURG D-79111
K001127 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404
K965133 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K981030 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K981029 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K061376 THERATEST LABORATORIES, INC. 1111 N. MAIN ST.
LOMBARD IL 60148
K981748 WIESLAB AB 1306 BAILES LN.
FREDERICK MD 21701
K981750 WIESLAB AB 1306 BAILES LN.
FREDERICK MD 21701
K974166 WIESLAB AB 1306 BAILES LN.
FREDERICK MD 21701
K974167 WIESLAB AB 1306 BAILES LN.
FREDERICK MD 21701
K243776 ZEUS Scientific 200 Evans Way
Branchburg NJ 08876
K964449 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K964446 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K964448 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K984034 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K984516 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K984315 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876
K040111 ZEUS SCIENTIFIC, INC. 200 EVANS WAY
BRANCHBURG NJ 08876




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