FDA 510(k) Applications for Medical Device:
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K120889 | AESKU DIAGNOSTICS |
87 PEDRICKTOWN-WOODSTOWN RD. | PEDRICKTOWN | NJ | 08067 |
| K153117 | AESKU. SYSTEMS GMBH & CO. KG |
MIKROFORUM RING 3 | WENDELSHEIM | 55234 | |
| K024222 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024221 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024230 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984397 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984398 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984399 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024229 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984400 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024217 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024227 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024231 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024225 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024224 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K024220 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K042680 | CORGENIX, INC. |
455 STATE STREET | DES PLAINES | IL | 60016 |
| K141827 | EUROIMMUN U.S., Inc. |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K131791 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K070763 | EUROIMMUN US LLC |
429 ROCKAWAY VALLEY ROAD | BOONTON TOWNSHIP | NJ | 07005 |
| K962276 | HEMAGEN DIAGNOSTICS, INC. |
34-40 BEAR HILL RD. | WALTLHAM | MA | 02154 |
| K013213 | HYPERION, INC. |
14100 S.W. 136TH ST. | MIAMI | FL | 33186 |
| K022800 | HYPERION, INC. |
14100 S.W. 136TH ST. | MIAMI | FL | 33186 |
| K172745 | IMMCO Diagnostics, Inc. |
60 Pineview Dr. | Buffalo | NY | 14228 |
| K983924 | IMMUNO CONCEPTS, INC. |
9779 BUSINESS PARK DR. | SACRAMENTO | CA | 95827 |
| K972145 | IMMUNO CONCEPTS, INC. |
9779 BUSINESS PARK DR. | SACRAMENTO | CA | 95827 |
| K160265 | Immuno Concepts, NA, Ltd. |
9825 Goethe Road; Suite 350 | Sacramento | CA | 95827 |
| K150155 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE ROAD | SAN DIEGO | CA | 92131 |
| K012163 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K970198 | SCIMEDX CORP. |
400 FORD RD. | DENVILLE | NJ | 07834 |
| K990915 | STELLAR BIO SYSTEMS, INC. |
9075 GUILFORD RD. | COLUMBIA | MD | 21046 |
| K001556 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K964165 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD. | PALM BEACH GARDENS | FL | 33410 |
| K201956 | Zeus Scientific, Inc. |
PO Box 38 | Raritan | NJ | 08869 |
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