FDA 510(k) Applications for Medical Device:
Anti-Rnp Antibody, Antigen And Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K984476 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K071210 | BIOMEDICAL DIAGNOSTICS (BMD) SA |
ACTIPOLE 25 | MARNE LA VALLEE CEDEX 2 | 77435 | |
| K990624 | COGENT DIAGNOTICS LTD. |
PENTLANDS SCIENCE PARK | MIDLOTHIAN, SCOTLAND | EH26 OPL | |
| K123261 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K140224 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K191085 | Genalyte, Inc. |
10520 Wateridge Circle | San Diego | CA | 92121 |
| K954897 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K954831 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K083117 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K993589 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K022017 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60068 |
| K000752 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60068 |
| K983465 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
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