FDA 510(k) Applications for Medical Device:
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K111860 | BECTON DICKINSON & CO. |
7 LOVETON CIR. | BALTIMORE | MD | 21152 |
| K062948 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K121539 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K203429 | Cepheid |
904 Caribbean Drive | Sunnyvale | CA | 94089 |
| K060540 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K222638 | Cepheid |
904 Caribbean Drive | Sunnyvale | CA | 94089 |
| K181156 | Diagenode |
Rue du Bois Saint Jean 3 | Seraing | 4102 | |
| K182467 | DiaSorin Molecular LLC |
11331 Valley View Street | Cypress | CA | 90630 |
| K170557 | GenePOC Inc. |
360 rue Franquet | Quebec | G1P 4N3 | |
| K143312 | GREAT BASIN CORPORATION |
2441 SOUTH 3850 WEST | Salt Lake City | UT | 84120 |
| K090191 | HANDYLAB, INC |
5230 S STATE ROAD | ANN ARBOR | MI | 48108 |
| K022504 | INFECTIO DIAGNOSTIC, INC. |
P.O. BOX 103 | BALDWIN | MD | 21013 |
| K162772 | LUMINEX CORPORATION |
12212 TECHNOLOGY BLVD. | AUSTIN | TX | 78727 |
| K112125 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K121044 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K173725 | NeuMoDx Molecular, Inc. |
1250 Eisenhower Place | Ann Arbor | MI | 48108 |
| K133503 | QUIDEL CORPORATION |
2005 EAST STATE ST., SUITE 100 | ATHENS | OH | 45701 |
| K173250 | Quidel Corporation |
2005 East State Street, Suite 100 | Athens | OH | 45701 |
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