FDA 510(k) Applications for Medical Device:
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K984396 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K952567 | COGENT DIAGNOTICS LTD. |
KINGS BUILDINGS, WEST MAINS RD | EDINBURGH | EH9 3JF | |
| K994424 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K974694 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K083381 | EUROIMMUN US INC |
95 WASHINGTON ST | MORRISTOWN | NJ | 07960 |
| K960091 | HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. | WEST SACRAMENTO | CA | 95691-6221 |
| K001900 | HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. | WEST SACRAMENTO | CA | 95691-6221 |
| K962730 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K954893 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K101319 | IMMCO DIAGNOSTICS, INC. |
60 PINEVIEW DR. | BUFFALO | NY | 14228-2120 |
| K960182 | MARDX DIAGNOSTICS, INC. |
5919 FARNSWORTH CT. | CARLSBAD | CA | 92008 |
| K000477 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780 |
| K040811 | PHARMACIA DEUTSCHLAND GMBH |
DIAGNOSTICS DIVISION | FREIBURG | D-79111 | |
| K980391 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K993727 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K062183 | THE BINDING SITE, LTD. |
2425 W. OLYMPIC BLV | SANTA MONICA | CA | 90404 |
| K983422 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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