FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K210596 | Abbott Laboratories |
Dept 09AA, Bldg. Ap8-1, 100 Abbott Park Rd. | Abbott Park | IL | 60064 |
| K954575 | ABBOTT LABORATORIES |
100 ABBOTT MALL | BUFFALO | NY | 14225 |
| K954576 | ABBOTT LABORATORIES |
100 ABBOTT MALL | BUFFALO | NY | 14225 |
| K010755 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K955760 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K971989 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K012183 | BAYER DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052 |
| K032162 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K031506 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K080869 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K003259 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K002453 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K973448 | BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K013839 | BIO-RAD |
6565 185TH AVENUE NE | REDMOND | WA | 98052 |
| K013837 | BIO-RAD |
6565 185TH AVENUE NE | REDMOND | WA | 98052 |
| K090847 | Bio-Rad Laboratories |
6565 185TH AVE, NE | REDMOND | WA | 98052 |
| K944867 | BIO-WHITTAKER, INC., A CAMBREX CO. |
8830 BIGGS FORD RD. | WALKERSVILLE | MD | 21793-8415 |
| K101946 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K993319 | BIOMERIEUX, INC. |
1022 HINGHAM ST. | ROCKLAND | MA | 02370 |
| K950671 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K012075 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K962936 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K001707 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K981498 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K052499 | DIASORIN S.P.A. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K131441 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K132234 | DIASORIN, INC. |
1951 NORTHWESTERN AVE | STILLWATER | MN | 55082-0285 |
| K962343 | GULL LABORATORIES, INC. |
1011 MURRAY HOLLADAY RD. | SALT LAKE CITY | UT | 84117 |
| K963296 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K963297 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K963289 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K971441 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K960092 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K971672 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K162678 | ROCHE DIAGNOSTICS |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K073501 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K102681 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K142826 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K984317 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K984170 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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