FDA 510(k) Applications for Medical Device:
Anti-Sm Antibody, Antigen And Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K984479 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K024219 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K990625 | COGENT DIAGNOTICS LTD. |
PENTLANDS SCIENCE PARK | MIDLOTHIAN, SCOTLAND | EH26 OPL | |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER |
7914 VIA CALLENDO | CARLSBAD | CA | 92009 |
| K954896 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K123593 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K954830 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K183007 | Phadia AB |
Rapsgatan 7P | Uppsala | SE 754 50 | |
| K202067 | Phadia AB |
Rapsgatan 7P | Uppsala | SE 754 50 | |
| K132631 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K000312 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K980540 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K980811 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K000755 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60068 |
| K042629 | SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MUNZINGER STRASSE 7 | FREIBURG | D-79111 | |
| K051066 | THERATEST LABORATORIES, INC. |
1111 N. MAIN ST. | LOMBARD | IL | 60148 |
| K983420 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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