FDA 510(k) Applications for Medical Device:
Urease, Photometric, Urea Nitrogen
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K113389 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K103615 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K123322 | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K972012 | CHOLESTECH CORP. |
3347 INVESTMENT BLVD. | HAYWARD | CA | 94545 |
| K132462 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K961196 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K001885 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K190326 | Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive | Rochester | NY | 14626 |
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