FDA 510(k) Applications for Medical Device:
Analyzer, Chemistry, Micro, For Clinical Use
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K040332 |
ARKRAY, INC. |
510 FURNACE DOCK RD.
| CORTLANDT MANOR |
NY |
10567 |
K993634 |
CARESIDE, INC. |
6100 BRISTOL PKWY.
| CULVER CITY |
CA |
90230 |
K965103 |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST.
| LOS ANGELES |
CA |
90045-5597 |
K973177 |
DIAMEDIX CORP. |
2140 NORTH MIAMI AVE.
| MIAMI |
FL |
33127 |
K052794 |
DIASORIN, INC. |
1951 NORTHWESTERN AVE.
| STILLWATER |
MN |
55082 |
K980056 |
EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY.
| CULVER CITY |
CA |
90230 |
K964409 |
HCL LABORATORY SYSTEMS, INC. |
362 CAMINO BAILEN
| ESCONDIDO |
CA |
92029 |
K013654 |
PRECISION SYSTEMS, INC. |
16 TECH CIRCLE
| NATICK |
MA |
01760 |
K033734 |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD.
| INDIANAPOLIS |
IN |
46250 |
K964506 |
ROCHE MOLECULAR SYSTEMS, INC. |
1080 U.S. HIGHWAY 202
| SOMERVILLE |
NJ |
08876-3711 |
K012966 |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DR.
| PLEASANTON |
CA |
94588-2722 |
K961209 |
SEAC S.R.L. |
45 PONTIAL RO
| NEWTON |
MA |
02168 |
K971491 |
SYNERMED, INC. |
1688 50TH AVENUE,
| QUEBEC, CANADA |
|
H8T 2V5 |
K973628 |
VITAL SCIENTIFIC N.V. |
ONE GATEWAY CENTER SUITE 415
| NEWTON |
MA |
02158 |
|
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