FDA 510(k) Applications for Medical Device:
Assay, Heparin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013637 | AMERICAN DIAGNOSTICA, INC. |
222 RAILROAD AVE. | GREENWICH | CT | 06830 |
| K013318 | AMERICAN DIAGNOSTICA, INC. |
222 RAILROAD AVE. | GREENWICH | CT | 06830 |
| K013305 | CARDIOVASCULAR DIAGNOSTICS, INC. |
9401 GLOBE CENTER DR. | MORRISVILLE | NC | 27560 |
| K111822 | DIAGNOSTICA STAGO, INC. |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K010455 | DIAGNOSTICA-STAGO |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K952667 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K050367 | HYPHEN BIOMED |
6560 GOVE CT. | MASON | OH | 45040 |
| K983178 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K213464 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K090209 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K980242 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K010193 | INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. | EDISON | NJ | 08820 |
| K972209 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K965076 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K162540 | SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH |
EMIL-VON BEHRING STR 76 | MARBURG | 35041 |
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