FDA 510(k) Applications for Medical Device:
Respiratory Virus Panel Nucleic Acid Assay System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K191534 | Abbott Diagnostics Scarborough, Inc. |
10 Southgate Road | Scarborough | ME | 04074 |
| K232775 | Abbott Diagnostics Scarborough, Inc. |
10 Southgate Road | Scarborough | ME | 04074 |
| K121003 | ABBOTT LABORATORIES |
1300 EAST TOUHY AVENUE | DES PLAINES | IL | 60018 |
| K141520 | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
10 Southgate Rd | Scarborough | ME | 04074 |
| K171792 | Alere Scarborough, Inc. |
10 Southgate Road | Scarborough | ME | 04074 |
| K163266 | ALERE SCARBOROUGH, INC. |
10 SOUTHGATE RD | Scarborough | ME | 04074 |
| K151464 | ALERE SCARBOROUGH, INC. |
10 SOUTHGATE ROAD | SCARBOROUGH | ME | 04074 |
| K173932 | Alere Scarborough, Inc. |
10 Southgate Road | Scarborough | ME | 04074 |
| K161375 | ALERE SCARBOROUGH, INC. |
10 SOUTHGATE ROAD | SCARBOROUGH | ME | 04074 |
| K192485 | Applied BioCode, Inc. |
10020 Pioneer Blvd Suite 102 | Santa Fe Springs | CA | 90670 |
| K121942 | ARGENE SA |
PARC TECHNOLOGIQUE DELTA SUD | VARILHES | 09120 | |
| K123620 | BIOFIRE DIAGNOSTICS, INC. |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K160068 | BioFire Diagnostics, LLC |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K143080 | BioFire Diagnostics, LLC |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K170604 | BioFire Diagnostics, LLC |
515 Colorow Drive | Salt Lake City | UT | 84108 |
| K152579 | BIOFIRE DIAGNOSTICS, LLC |
390 WAKARA WAY | SALT LAKE CITY | UT | 84108 |
| K123191 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K142045 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089-1189 |
| K151226 | CEPHEID |
904 CARIBBEAN DRIVE | Sunnyvale | CA | 94089 |
| K162456 | CEPHEID |
904 CARIBBEAN DRIVE | SUNNYVALE | CA | 94089 |
| K181289 | Cepheid |
904 Caribbean Drive | Sunnyvale | CA | 94089 |
| K171552 | Cepheid |
904 Caribbean Drive | Sunnyvale | CA | 94089-1189 |
| K162331 | CEPHEID |
904 CARIBBEAN DRIVE | Sunnyvale | CA | 94089 |
| K180218 | Cepheid |
904 Caribbean Drive | Sunnyvale | CA | 94089 |
| K201505 | DiaSorin Molecular LLC |
11331 Valley View Street | Cypress | CA | 90630 |
| K142365 | FOCUS DIAGNOSTICS |
11331 Valley View Street | CYPRESS | CA | 90630 |
| K102170 | FOCUS DIAGNOSTICS, INC. |
11331 VALLEY VIEW ST | CYPRESS | CA | 90630 |
| K152408 | FOCUS DIAGNOSTICS, INC. |
11331 VALLEY VIEW STREET | CYPRESS | CA | 90630 |
| K120413 | FOCUS DIAGNOSTICS, INC. |
11331 Valley View Street | CYPRESS | CA | 90630 |
| K132159 | GEN-PROBE PRODESSE, INC |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K102952 | GEN-PROBE PRODESSE, INC |
W229 N1870 WESTWOOD DR | WAUKESHA | WI | 53186 |
| K110968 | GEN-PROBE PRODESSE, INC |
W229 N1870 WESTWOOD DR | WAUKESHA | WI | 53186 |
| K132129 | GEN-PROBE PRODESSE, INC. |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186 |
| K163636 | GENMARK DIAGNOSTICS, INCORPORATED |
5964 LA PLACE COURT | CARLSBAD | CA | 92008 |
| K231017 | Hologic, Inc. |
10210 Genetic Center Dr | SAN DIEGO | CA | 92121 |
| K172629 | Hologic, Inc. |
10210 Genetic Center Drive | San Diego | CA | 92121 |
| K171963 | Hologic, Inc. |
10210 Genetic Center Drive | San Diego | CA | 92121 |
| K153219 | HOLOGIC, INC. |
10210 GENETIC CENTER DRIVE | SAN DIEGO | CA | 92121 |
| K103175 | IDAHO TECHNOLOGY, INC. |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K110764 | IDAHO TECHNOLOGY, INC. |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K120267 | IDAHO TECHNOLOGY, INC. |
390 Wakara Way | Salt Lake City | UT | 84108 |
| K131584 | INTELLIGENT MEDICAL DEVICES, INC |
180 CABOT ST. | BEVERLY | MA | 01915 |
| K111387 | IQUUM INC |
700 NICKERSON ROAD | MARLBOROUGH | MA | 01762-4663 |
| K153544 | IQuum, Inc. |
700 Nickerson Road | Marlborough | MA | 01752 |
| K163628 | JANSSEN PHARMACEUTICA NV |
TURNHOUTSEWEG 30 | BEERSE | 2340 | |
| K161220 | LUMINEX CORPORATION |
12212 TECHNOLOGY BLVD | AUSTIN | TX | 78727 |
| DEN070013 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K152386 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVENUE | TORONTO | M5G 1Y8 | |
| K193167 | Luminex Molecular Diagnostics, Inc. |
439 University Avenue | Toronto | M5g 1y8 | |
| K242613 | Luminex Molecular Diagnostics, Inc. |
439 University Ave. | Toronto | M5G 1Y8 | |
| K112781 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K081483 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K103776 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K091667 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K112199 | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. | TORONTO, ONTARIO | M5G 1Y8 | |
| K181443 | Mesa Biotech, Inc. |
6190 Cornerstone Court, Suite 220 | San Diego | CA | 92121 |
| K143653 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K083088 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K093337 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K092566 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K092957 | NANOSPHERE, INC |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K103209 | NANOSPHERE, INC. |
4088 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K081030 | PRODESSE, INC. |
W229 N1870 WESTWOOD DR. | WAUKESHA | WI | 53186 |
| K092500 | PRODESSE, INC. |
W229N1870 WESTWOOD DR. | WAUKESHA | WI | 53186 |
| K073029 | PRODESSE, INC. |
W229 N1870 WESTWOOD DR. | WAUKESHA | WI | 53186 |
| K183597 | QIAGEN GmbH |
Qiagen Strasse 1 | Hilden | 40724 | |
| K113323 | QIAGEN, GMBH |
1201 CLOPPER RD | GAITHERSBURG | MD | 20878 |
| K112172 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K131813 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K141931 | QUIDEL CORPORATION |
2005 E State St Suite 100 | ATHENS | OH | 45701 |
| K161814 | Quidel Corporation |
2005 East State Street, Suite 100 | Athens | OH | 45701 |
| K171974 | Quidel Corporation |
2005 East State Street, Suite 100 | Athens | OH | 45701 |
| K210234 | Roche Molecular Systems, Inc. |
4300 Hacienda Drive | Pleasanton | CA | 94588-2722 |
| K213822 | Roche Molecular Systems, Inc. |
4300 Hacienda Drive | Pleasanton | CA | 94588-2722 |
| K191729 | Roche Molecular Systems, Inc. |
4300 Hacienda Drive | Pleasanton | CA | 94588-2722 |
| K200065 | Roche Molecular Systems, Inc. |
4300 Hacienda Drive | Pleasanton | CA | 94588-2722 |
| K111775 | U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY |
1430 VETERANS DRIVE | FORT DETRICK | MD | 21702 |
| K152523 | U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
1430 VETERANS DRIVE | FORT DETRICK | MD | 21702-9232 |
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