FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Digoxin
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K061249 |
ABBOTT LABORATORIES |
D 9VA, BLDG. AP6C-2
| ABBOTT PARK |
IL |
60064-3500 |
K980521 |
BAYER CORP. |
511 BENEDICT AVE.
| TARRYTOWN |
NY |
10591-5097 |
K033007 |
BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE.
| TARRYTOWN |
NY |
10591-5097 |
K983151 |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110
| BREA |
CA |
92822 |
K982935 |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104
| BREA |
CA |
92822-8000 |
K963062 |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD.
| BREA |
CA |
92621 |
K082953 |
BIOKIT S.A. |
CAN MALE S/N
| BARCELONA |
|
08186 |
K970881 |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN.
| CONCORD |
CA |
94524 |
K970883 |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN.
| CONCORD |
CA |
94524 |
K973112 |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN.
| CONCORD |
CA |
94524 |
K012301 |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST.
| LOS ANGELES |
CA |
90045-5597 |
K963835 |
DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE.
| SUNNYVALE |
CA |
94086 |
K983323 |
DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE.
| SUNNYVALE |
CA |
94086 |
K011302 |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD.
| CRUMLIN, CO. ANTRIM |
|
BT29 4QY |
K102346 |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD.
| CRUMLIN, COUNTY ANTRIM |
|
BT29 4QY |
K153301 |
ROCHE DIAGNOSTICS |
9115 HAGUE ROAD
| INDIANAPOLIS |
IN |
46250 |
K023058 |
SERADYN |
7998 GEORGETOWN RD.
| INDIANAPOLIS |
IN |
46268 |
K093441 |
SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101
| NEWARK |
DE |
19714-6101 |
K193397 |
Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue
| Tarrytown |
NY |
10591 |
K972794 |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE.
| ST.LOUIS |
MO |
63103 |
K011920 |
SYVA CO., DADE BEHRING, INC. |
20400 MARIANI AVE.
| CUPERTINO |
CA |
95014 |
|
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