FDA 510(k) Applications for Medical Device:
Photometric Method, Magnesium
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991761 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K040115 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K091910 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K173294 | Abbott Laboratories |
1921 Hurd Drive | Irving | TX | 75038 |
| K181748 | Abbott Laboratories |
1921 Hurd Drive | Irving | TX | 75038 |
| K981192 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K981791 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K122302 | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K983416 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K991717 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K040508 | CLINICAL DATA, INC. |
1075 W. LAMBERT ROAD | BREA | CA | 92821 |
| K964915 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K063208 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K030010 | ELAN DIAGNOSTICS |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K003835 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K092737 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K162200 | RANDOX LABORATORIES LTD |
55 DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K974606 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K111915 | SEKISUI DIAGNOSTICS P.E.I. INC. |
70 WATTS AVENUE | PRINCE EDWARD ISLAND | C1E2B9 | |
| K162399 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DRIVE, PO BOX 6101 MS 514 | NEWARK | DE | 19711 |
| K012326 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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