FDA 510(k) Applications for Medical Device:
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991665 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K991664 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K023640 | ABAXIS, INC. |
3240 WHIPPLE RD. | UNION CITY | CA | 94587 |
| K981224 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K981580 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K051962 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K982539 | AC BIOCHEMICALS, INC. |
17955 SKY PARK CIRCLE, SUITE J | IRVINE | CA | 92614 |
| K072836 | ACCUTECH, LLC. |
150 CHERRY LANE ROAD | EAST STROUDSBURG | PA | 18301 |
| K050632 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K100010 | BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD | BREA | CA | 92821 |
| K042195 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K040767 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K963213 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K132711 | CAROLINA LIQUID CHEMISTRIES CORP. |
575 N. PATTERSON AVE. | WINSTON-SALEM | NC | 27101 |
| K071706 | CLINICAL DATA, INC. |
1075 WEST LAMBERT ROAD | BREA | CA | 92821-2944 |
| K053157 | DADE BEHRING, INC. |
P.O. BOX 6101 BUILDING 500 | NEWARK, | DE | 19714 |
| K041090 | DENKA SEIKEN CO., LTD. |
1-2-2, MINAMIHONCHO, | NIIGATA | 959-1695 | |
| K041928 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PE | C1E 2A6 | |
| K072395 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K013152 | ELAN HOLDINGS, INC. |
1075 W. LAMBERT RD., SUITE D | BREA | CA | 92821 |
| K103747 | ELITECHGROUP SEPPIM S.A.S. |
21720 23RD DR SE, SUITE 150 | BOTHELL | WA | 98021 |
| K981899 | EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K971162 | GENZYME CORP. |
101 BINNEY ST. ONE KENDALL | CAMBRIDGE | MA | 02139-1562 |
| K971190 | GENZYME CORP. |
ONE KENDALL SQUARE | CAMBRIDGE | MA | 02139 |
| K021316 | GENZYME CORP. |
ONE KENDALL SQUARE | CAMBRIDGE | MA | 02139 |
| K014018 | IMI |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K021671 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K990581 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K111516 | LIPOSCIENCE, INC |
2500 Sumner Blvd | Raleigh | NC | 27616 |
| K073497 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K111036 | MEDICA CORPORATION |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K014015 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K014032 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K120609 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K042006 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K100550 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K062092 | PREMD, INC. |
16809 BRIARDALE ROAD | ROCKVILLE | MD | 20855 |
| K153435 | Randox Laboratories Ltd |
55 Diamond Road | Ardmore Crumlin | BT29 4QY | |
| K970735 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K982341 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K973988 | REFERENCE DIAGNOSTICS, INC. |
23 CROSBY DR. | BEDFORD | MA | 01730 |
| K971902 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K033610 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K012286 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K162593 | Roche Diagnostics Operations (RDO) |
9115 Hague Road | Indianapolis | IN | 46250 |
| K971526 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K972041 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
| K032932 | STANBIO LABORATORY |
1261 NORTH MAIN ST. | BOERNE | TX | 78006 |
| K080125 | WAKO CHEMICALS USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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