FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Methadone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013001 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K012595 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K010015 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K010014 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K012164 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K023869 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K182779 | ARK Diagnostics, Inc. |
48089 Fremont Boulevard | Fremont | CA | 94538 |
| K152025 | ASSURE TECH. CO., LTD. |
2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD | HANGZHOU | 310030 | |
| K973069 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K092048 | BIOSITE INCORPORATED |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K060791 | BIOSITE INCORPORATED |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K980746 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K002417 | BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E | IRVINE | CA | 92618 |
| K011131 | COZART BIOSCIENCE LTD. |
45 MILTON PARK | OXFORDSHIRE OX14 4RU | OX14 4RU | |
| K000466 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K972526 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K131232 | Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. | GAITHERSBURG | MD | 20878 |
| K023252 | ICN BIOMEDICALS, INC. |
1429 ROLLINS RD. | BURLINGAME | CA | 94010 |
| K151395 | Immunalysis Corporation |
829 Towne Center Drive | Pomona | CA | 91767 |
| K192433 | Lin-Zhi International, Inc |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K170416 | Lin-Zhi International, Inc. |
2945 Oakmead Village Court | Santa Clara | CA | 95051 |
| K023317 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K031797 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K051058 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K023617 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K002010 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062637 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K013796 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K982938 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K962673 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991080 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K092258 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K040570 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K092272 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K983703 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K021512 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K021505 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K981314 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K023856 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K994005 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K010962 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
| K081378 | Thermo Fisher Scientific |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K160793 | W.H.P.M., INC. |
5358 IRWINDALE AVE. | IRWINDALE | CA | 91706 |
| K151441 | W.H.P.M., INC. |
5358 IRWINDALE AVE. | IRWINDALE | CA | 91706 |
| K052197 | W.H.P.M., INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
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