FDA 510(k) Applications for Medical Device:
Panels, Test, Susceptibility, Antimicrobial
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K960366 | ACCUMED INTL., INC. |
29299 CLEMENS RD. | WESTLAKE | OH | 44145 |
| K983306 | ACCUMED INTL., INC. |
29299 CLEMENS RD. | WESTLAKE | OH | 44145 |
| K983309 | ACCUMED INTL., INC. |
29299 CLEMENS RD. | WESTLAKE | OH | 44145 |
| K172912 | Beckman Coulter Inc. |
2040 Enterprise Bldv | West Sacramento | CA | 95691 |
| K172255 | Beckman Coulter, Inc |
1584 Enterprise Blvd | West Sacramento | CA | 95691 |
| K193536 | Beckman Coulter, Inc |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K172337 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K183127 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K250084 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K202343 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K162740 | BECKMAN COULTER, INC. |
1584 ENTERPRISE BLVD | WEST SACRAMENTO | CA | 95691 |
| K193358 | Beckman Coulter, Inc. |
1584 Enterprise Blvd | West Sacramento | CA | 95630 |
| K201423 | Beckman Coulter, Inc. |
1584 Enterprise Blvd. | West Sacramento | CA | 95691 |
| K010418 | DADE BEHRING, INC. |
2040 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K020160 | DADE BEHRING, INC. |
2040 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K033940 | DADE BEHRING, INC. |
2040 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K062777 | DADE BEHRING, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K062773 | DADE BEHRING, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K962150 | DADE INTL., INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO, | CA | 95691 |
| K010159 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K003619 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K972799 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K993102 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K021111 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K021184 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K021078 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K020627 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K020626 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K020939 | DADE MICROSCAN, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K001721 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K010508 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K030620 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K973317 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K011116 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K083262 | SIEMENS HEALTHCARE DIAGNOSTICS |
2040 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K091264 | SIEMENS HEALTHCARE DIAGNOSTICS |
1584 ENTERPRISE BLVD | WEST SACRAMENTO | CA | 95691 |
| K091949 | SIEMENS HEALTHCARE DIAGNOSTICS |
1584 ENTERPRISE BLVD | WEST SACRAMENTO | CA | 95691 |
| K150039 | Siemens Healthcare Diagnostics Inc. |
1584 ENTERPRISE BLVD | WEST SACRAMENTO | CA | 95691 |
| K111394 | Siemens Healthcare Diagnostics Inc. |
1584 ENTERPRISE BLVD | WEST SACRAMENTO | CA | 95691 |
| K123933 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K131275 | SIEMENS HELATHCARE DIAGNOSTICS INC. |
1584 ENTERPRISE BLVD. | WEST SACRAMENTO | CA | 95691 |
| K013368 | TREK DIAGNOSTIC SYSTEMS, INC. |
29299 CLEMENS RD., SUITE 1-K | WESTLAKE | OH | 44145 |
| K013195 | TREK DIAGNOSTIC SYSTEMS, INC. |
29299 CLEMENS RD., SUITE 1-K | WESTLAKE | OH | 44145 |
| K024357 | TREK DIAGNOSTIC SYSTEMS, INC. |
982 KEYNOTE CIRCLE SUITE 6 | CLEVELAND | OH | 44131 |
| K024353 | TREK DIAGNOSTIC SYSTEMS, INC. |
982 KEYNOTE CIRCLE SUITE 6 | CLEVELAND | OH | 44131 |
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