FDA 510(k) Applications for Medical Device:
Azo Dye, Calcium
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K244042 | Abbott Ireland |
Diagnostic Divison | Lisnamuck | ||
| K981578 | ABBOTT LABORATORIES |
160B REGAL ROW | DALLAS | TX | 75247 |
| K062855 | ABBOTT LABORATORIES |
1921 HURD DR. | IRVING | TX | 75038 |
| K981232 | ABBOTT MFG., INC. |
1920 HURD DR. | IRVING | TX | 75038 |
| K072356 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K983789 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K051757 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K151113 | ELITechGroup |
ZONE INDUSTRIELLE | Sees | 61500 | |
| K040972 | GENCHEM, INC. |
471 W. LAMBERT RD., SUITE 107 | BREA | CA | 92821 |
| K022049 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K981794 | HICHEM DIAGNOSTICS |
231 NORTH PUENTE ST. | BREA | CA | 92621 |
| K123171 | HORIBA ABX S.A.S. |
PARC EUROMEDECINE | MONTPELLIER CEDEX 4, HERAULT | 34184 | |
| K191396 | Horiba ABX SAS |
Parc Euromedecine, Rue du Caducee û BP7290 | Montpellier Cedex 4 | 341184 | |
| K011441 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K961226 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K061575 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K982035 | OLYMPUS DIAGNOSTICA GMBH |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747 |
| K072443 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K072440 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K182042 | Randox Laboratories Ltd. |
55 Diamond Road | Crumlin | BT29 4QY | |
| K974607 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K083386 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K963536 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K073355 | THERMO FISHER SCIENTIFIC OY |
2 RATASTIE | VANTAA | FIN-01621 | |
| K120626 | VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
189-199 BROWNS RD | NOBLE PARK | 3174 | |
| K021334 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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