FDA 510(k) Applications for Medical Device:
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040953 | AESKU, INC |
8880 NORTHWEST 18TH TERRACE | MIAMI | FL | 33172 |
| K962052 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K962053 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K962057 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K962055 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
7 COLCHESTER RD. | WINDHAM | NH | 03087 |
| K962062 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K962054 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K983655 | COGENT DIAGNOTICS LTD. |
PENTLANDS SCIENCE PARK | MIDLOTHIAN, SCOTLAND | EH26 OPL | |
| K964385 | ELIAS USA, INC. |
373 280TH ST. | OSCEOLA | WI | 54020 |
| K963291 | ELIAS USA, INC. |
373 280TH ST. | OSCEOLA | WI | 54020 |
| K131185 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K131330 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | Davis | CA | 95618 |
| K980337 | HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. | WEST SACRAMENTO | CA | 95691-6221 |
| K962450 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K041102 | IMMCO DIAGNOSTICS, INC. |
60 PINEVIEW DR. | BUFFALO | NY | 14228-2120 |
| K151559 | IMMCO DIAGNOSTICS, INC. |
60 PINEVIEW DR. | BUFFALO | NY | 14228 |
| K992041 | IMMUNO CONCEPTS, INC. |
2280 SPRINGLAKE RD. | DALLAS | TX | 75234 |
| K123880 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K003959 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131-1234 |
| K954380 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K000934 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780-7033 |
| K993635 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780 |
| K993636 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780 |
| K954829 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K954814 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K954815 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K954832 | ORGENTEC |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K030929 | ORGENTEC DIAGNOSTIKA GMBH |
8201 CENTRAL AVE. NE, SUITE P | MINNEAPOLIS | MN | 55432 |
| K182353 | Phadia AB |
Rapsgatan 7P | Uppsala | SE 754 50 | |
| K140493 | PHADIA GMBH |
4169 COMMERCIAL AVE | PORTAGE | MI | 49002 |
| K083188 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K993109 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K993108 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K040810 | PHARMACIA DEUTSCHLAND GMBH |
DIAGNOSTICS DIVISION | FREIBURG | D-79111 | |
| K980810 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K040200 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60016 |
| K994071 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60068 |
| K022018 | RHIGENE, INC. |
455 STATE ST., | DES PLAINES | IL | 60068 |
| K050625 | SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MUNZINGER STRASSE 7 | FREIBURG | D-79111 | |
| K050967 | SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MUNZINGER STRASSE 7 | FREIBURG | D-79111 | |
| K004019 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K002559 | THERATEST LABORATORIES, INC. |
2201 WEST CAMPBELL PARK DR. | CHICAGO | IL | 60612-3501 |
| K040291 | THERATEST LABORATORIES, INC. |
1111 N. MAIN ST. | LOMBARD | IL | 60148 |
| K024031 | THERATEST LABORATORIES, INC. |
1111 N. MAIN ST. | LOMBARD | IL | 60148 |
| K955481 | THERATEST LABORATORIES, INC. |
2201 WEST CAMPBELL PARK DR. | CHICAGO | IL | 60612-3501 |
| K000880 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K983378 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K000879 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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