FDA 510(k) Applications for Medical Device:
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K020488 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K971324 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K034000 | CLINICAL DATA, INC. |
1075 WEST LAMBERT ROAD | BREA | CA | 92821-2944 |
| K043546 | DADE BEHRING, INC. |
500 GBC DR., M/S 514 | NEWARK | DE | 19714 |
| K010871 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K964346 | DADE INTL., INC. |
9750 N.W. 25TH ST. | MIAMI | FL | 33172 |
| K971113 | DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST | ARLINGTON | TX | 76011 |
| K961281 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K960088 | DIAGNOSTIC CHEMICALS LTD. |
16 FIRST ST. | CHARLOTTETOWN, P.E.I. | C1E1B0 | |
| K933722 | HORIZON DIAGNOSTICS, INC. |
3660 PLAZA DRIVE,STE.4 | ANN ARBOR | MI | 48108 |
| K113830 | LIPOSCIENCE |
2500 SUMMER BLVD. | RALEIGH | NC | 27616 |
| K963424 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K063804 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K130332 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K150819 | Randox Laboratories Limited |
55 Diamond Road | Crumlin | BT29 4Qy | |
| K102993 | SEPPIM S.A.S. |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K133067 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |
| K961477 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
| K953971 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
| K993466 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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