FDA 510(k) Applications for Medical Device:
Radioimmunoassay, Testosterones And Dihydrotestosterone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983212 | ABBOTT LABORATORIES |
100/200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K152155 | Abbott Laboratories |
100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 | Abbott Park | IL | 60064 |
| K120009 | ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD | ABBOTT PARK | IL | 60064 |
| K041866 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K963080 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K083867 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K223405 | Beckman Coulter, Inc. |
1000 Lake Hazeltine Drive | Chaska | MN | 55318 |
| K001935 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K002294 | BIOCHECK, INC. |
9418 LASAINE AVE. | NORTHRIDGE | CA | 91325 |
| K955102 | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
100 CASCADE DR. | ALLENTOWN | PA | 18103-9562 |
| K060818 | BIOKIT S.A. |
CAN MALE S/N | BARCELONA | 08186 | |
| K152185 | BIOKIT, S.A. |
CAN MALE, S/N | LLICA D AMUNT | 08186 | |
| K021326 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K964889 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K955870 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K032881 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K971823 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K001086 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
445 MEDICAL CENTER BLVD. | WEBSTER | TX | 77598 |
| K030730 | DIAGNOSTICS BIOCHEM CANADA, INC. |
1020 HARGRIEVE RD. | LONDON, ONTARIO | N6E 1P5 | |
| K014120 | DIAGNOSTICS BIOCHEM CANADA, INC. |
1020 HARGRIEVE RD. | LONDON, ONTARIO | N6E 1P5 | |
| K201908 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082 |
| K122793 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K000043 | DRG INTL., INC. |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K052649 | DRG INTL., INC. |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K190121 | Immunodiagnostic Systems Ltd. |
10 Didcot Way Boldon Business Park | Boldon | NE35 9PD | |
| K191350 | Immunotech s.r.o. |
Radiova 1 | Prague | 10227 | |
| K973900 | KMI DIAGNOSTICS, INC. |
818 51ST AVE., N.E. | MINNEAPOLIS | MN | 55421 |
| K181017 | Monobind Inc. |
100 North Pointe Drive | Lake Forest | CA | 92630 |
| K153577 | NanoEnTek USA Inc. |
5627 Stoneridge Drive Suite 304 | Pleasanton | CA | 94588 |
| K182521 | Qualigen, Inc. |
2042 Corte Del Nogal | Carlsbad | CA | 92011 |
| K101388 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92011-1438 |
| K021972 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92009 |
| K211685 | Roche Diagnostics |
9115 Hague Road, PO Box 50416 | Indianapolis | IN | 46250 |
| K102814 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K031717 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K093421 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K091867 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K151986 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K133491 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K191533 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K151529 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DR. P.O. BOX 6101 M/S 514 | NEWARK | DE | 19714 |
| K143075 | TOSOH BIOSCIENCE, INC. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K023091 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
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