FDA 510(k) Applications for Medical Device:
Reagents, Clostridium Difficile Toxin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964864 | ALEXON BIOMEDICAL, INC. |
1190 BORREGAS AVE. | SUNNYVALE | CA | 94089-1302 |
| K980185 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
7 LOVETON CIRCLE | SPARKS | MD | 21152-0999 |
| K081920 | BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
6146 NANCY RIDGE DR. | SAN DIEGO | CA | 92121 |
| K964887 | BIOMERIEUX VITEK, INC. |
1022 HINGHAM ST. | ROCKLAND | MA | 02370 |
| K072138 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K080931 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K991829 | BIOSTAR, INC. |
6655 LOOKOUT RD. | BOULDER | CO | 80301 |
| K091109 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K193490 | First Light Diagnostics, Inc. |
2 Omni Way | Chelmsford | MA | 01824 |
| K102242 | GENZYME CORPORATION |
31 NEW YORK AVENUE | FRAMINGHAM | MA | 01701 |
| K990664 | INTRACEL CORP. |
1330 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K032897 | IVD RESEARCH, INC. |
5909 SEA LION PLACE, SUITE D | CARLSBAD | CA | 92008 |
| K041003 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K955859 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K993914 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K090239 | PRODESSE, INC. |
W229 N1870 WESTWOOD DR. | WAUKESHA | WI | 53186 |
| K033479 | REMEL INC |
14000 UNITY STREET NW | RAMSEY | MN | 55303 |
| K041951 | REMEL INC |
12076 SANTA FE DRIVE | LENEXA | KS | 66215 |
| K030991 | TECHLAB, INC. |
1861 PRATT DR., STE. 1030 | BLACKSBURG | VA | 24060-6364 |
| K030992 | TECHLAB, INC. |
1861 PRATT DR., STE. 1030 | BLACKSBURG | VA | 24060-6364 |
| K082499 | TECHLAB, INC. |
2001 KRAFT DR. | BLACKSBURG | VA | 24060-6358 |
| K030404 | TECHLAB, INC. |
1861 PRATT DR., STE. 1030 | BLACKSBURG | VA | 24060-6364 |
| K003306 | TECHLAB, INC. |
VPI RESEARCH PARK | BLACKSBURG | VA | 24060 |
| K050891 | TECHLAB, INC. |
2001 KRAFT DR. | BLACKSBURG | VA | 24060-6358 |
| K971182 | TECHLAB, INC. |
1861 PRATT DR. | BLACKSBURG | VA | 24060-6364 |
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