FDA 510(k) Applications for Medical Device:
Colorimeter, Photometer, Spectrophotometer For Clinical Use
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974762 | AWARENESS TECHNOLOGY, INC. |
1995 SW MARTIN HWY. | PALM CITY | FL | 34990 |
| K962113 | COLUMBIA BIOSCIENCE, INC. |
182 THOMAS JOHSON DR. | FREDERICK | MD | 21702 |
| K961183 | COLUMBIA BIOSCIENCE, INC. |
182 THOMAS JOHSON DR. | FREDERICK | MD | 21702 |
| K980120 | DIGENE CORP. |
9000 VIRGINIA MANOR RD., | BELTSVILLE | MD | 20705 |
| K962166 | IGEN, INC. |
16020 INDUSTRIAL DR. | GAITHERSBURG | MD | 20877 |
| K013371 | OTSUKA PHARMACEUTICAL CO., LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K973938 | SFRI, INC. |
2082 MICHELSON DR., #100 | IRVINE | CA | 92612-1212 |
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