FDA 510(k) Applications for Medical Device:
Enzymatic Esterase--Oxidase, Cholesterol
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K130200 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K023642 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K203597 | Abbott Ireland Diagnostics Division |
Lisnamuck | Longford | ||
| K981476 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K981652 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K163406 | ACON LABORATORIES INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K180504 | ACON Laboratories, Inc. |
10125 Mesa Rim Road | San Diego | CA | 92121 |
| K960377 | ACTIMED LABORATORIES, INC. |
5 TERRI LN. | BURLINGTON | NJ | 08016 |
| K981181 | ACTIMED LABORATORIES, INC. |
5 TERRI LN. | BURLINGTON | NJ | 08016 |
| K113262 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K112538 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K122757 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K091413 | ALFA WASSERMANN, INC. |
4 HENDERSON DR. | WEST CALDWELL | NJ | 07006 |
| K042443 | ARKRAY, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K062026 | ATHEROTECH, INC. |
15217 SPRINGDALE STREET | HUNTINGTON BEACH | CA | 92649 |
| K132031 | AXIS-SHIELD POC AS |
P.O. BOX 6863 | OSLO | N-0504 | |
| K971505 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K011970 | BIOSAFE LABORATORIES, INC. |
100 FIELD DRIVE #240 | LAKE FOREST | IL | 60045 |
| K944458 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K971345 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K964660 | DADE INTL., INC. |
9750 N.W. 25TH ST. | MIAMI | FL | 33172 |
| K971072 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K000900 | ELAN HOLDINGS, INC. |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K982469 | ELAN PHARMA, INC. |
231 NORTH PUENTE ST. | BREA | CA | 92621 |
| K982118 | EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K992132 | GDS TECHNOLOGY, LLC. |
25235 LEER DR. | ELKHART | IN | 46514 |
| K111753 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K080623 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K181373 | Laboratory Corporation of America Holdings |
500 Perimeter Park Drive | Morrisville | NC | 27560 |
| K981345 | LIFESTREAM DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K993096 | LIFESTREAM TECHNOLOGIES, INC. |
51O CLEARWATER LOOP, SUITE 101 | POST FALLS | ID | 83854 |
| K000610 | LIFESTREAM TECHNOLOGIES, INC. |
51O CLEARWATER LOOP, SUITE 101 | POST FALLS | ID | 83854 |
| K072249 | MEDICA CORP. |
163 CABOT STREET | BEVERLY | MA | 01915 |
| K190490 | Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K991083 | OTSUKA PHARMACEUTICAL CO., LTD. |
2440 RESEARCH BLVD. | ROCKVILLE | MD | 20850 |
| K001032 | OTSUKA PHARMACEUTICAL CO., LTD. |
2440 RESEARCH BLVD. | ROCKVILLE | MD | 20850 |
| K013173 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K151545 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE ROAD | INDIANAPOLIS | IN | 46268 |
| K990688 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K981493 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K071593 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K022898 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K023558 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K150654 | RANDOX LABORATORIES, LTD. |
55 DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K972853 | REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. | SAN DIEGO | CA | 92111-1203 |
| K973284 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-1760 |
| K051376 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K031824 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K980667 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K992803 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K962890 | TRACE SCIENTIFIC LTD. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
| K120202 | VITAL DIAGNOSTICS PTY. LTD |
189 - 199 BROWNS ROAD | NOBLE PARK, VICTORIA | 3174 |
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