FDA 510(k) Applications for Medical Device:
Cresolphthalein Complexone, Calcium
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991111 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K050077 | ARKRAY, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K053401 | ARKRAY, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K971907 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K955939 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K023105 | ELAN DIAGNOSTICS |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K041009 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K130870 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K070249 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER, HERAULT | 34184 | |
| K000375 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K963292 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K083339 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10509 |
| K013652 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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