FDA 510(k) Applications for Medical Device:
Ldl & Vldl Precipitation, Hdl
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974733 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K980770 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K980772 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K992029 | ELAN DIAGNOSTICS |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K991789 | ELAN HOLDINGS, INC. |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K072523 | GENERAL ATOMICS |
12889 GREGG COURT | POWAY | CA | 92064 |
| K962186 | GENZYME CORP. |
ONE KENDALL SQUARE | CAMBRIDGE | MA | 02139 |
| K971573 | GENZYME CORP. |
ONE KENDALL SQUARE | CAMBRIDGE | MA | 02139 |
| K023784 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K984303 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012593 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K992002 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K990247 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K973369 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K143691 | Roche Diagnostics Operations (RDO) |
9115 Hague Road | Indianapolis | IN | 46250 |
| K050823 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K962723 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
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