FDA 510(k) Applications for Medical Device:
Antinuclear Antibody, Antigen, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K081104 | AESKU.DIAGNOSTICS |
MIKROFORUM RING 2 | WENDELSHEIM | D-55234 | |
| K984473 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984464 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024223 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984475 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024226 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984470 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024218 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984478 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024232 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K113610 | Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION | BENICIA | CA | 94510 |
| K041658 | BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. | REDMOND | WA | 98052 |
| K961815 | CONSOLIDATED TECHNOLOGIES, INC. |
2170 WOODWARD STREET, STE. 100 | AUSTIN | TX | 78744-1832 |
| K034013 | CORGENIX, INC. |
12061 TEJON ST. | WESTMINSTER | CO | 80234 |
| K021257 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K993294 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K030775 | IMMUNO CONCEPTS, N.A., LTD |
2280 SPRINGLAKE RD. | DALLAS | TX | 75234 |
| K210902 | Phadia AB |
Rapsgatan 7P | Uppsala | ||
| K082759 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K042416 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K021103 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K011244 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
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