FDA 510(k) Applications for Medical Device:
Test, Qualitative And Quantitative Factor Deficiency
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952126 | AALTO SCIENTIFIC LTD. |
1160 JOSHUA WAY | VISTA | CA | 92083-7836 |
| K051054 | AFFINITY BIOLOGICALS INC. |
1395 SANDHILL DRIVE | ANCASTER | L9G 4V5 | |
| K052825 | AFFINITY BIOLOGICALS INC. |
1395 SANDHILL DRIVE | ANCASTER, ONTARIO | L9G 4V5 | |
| K971519 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K012386 | AMERICAN DIAGNOSTICA, INC. |
222 RAILROAD AVE. | GREENWICH | CT | 06830 |
| K013168 | AMERICAN DIAGNOSTICA, INC. |
222 RAILROAD AVE. | GREENWICH | CT | 06830 |
| K013492 | AMERICAN DIAGNOSTICA, INC. |
222 RAILROAD AVE. | GREENWICH | CT | 06830 |
| K063323 | AMERICAN DIAGNOSTICA, INC. |
500 WEST AVENUE | STAMFORD | CT | 06902 |
| K962968 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K972116 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K983898 | BIOPOOL INTL., INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K062530 | BIOSITE INCORPORATED |
9975 SUMMERS RIDGE RD | SAN DIEGO | CA | 92121 |
| K983914 | CORGENIX, INC. |
12061 TEJON ST. | WESTMINSTER | CO | 80234 |
| K032139 | CORGENIX, INC. |
12061 TEJON ST. | WESTMINSTER | CO | 80234 |
| K971985 | CRESTAT DIAGNOSTICS, INC. |
374 GOODHILL RD. | WESTON | CT | 06883 |
| K002541 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K022290 | DADE BEHRING, INC. |
514 GBC DR. | NEWARK | DE | 19702 |
| K000649 | DADE BEHRING, INC. |
7739 NW 48 ST. | MIAMI | FL | 33166 |
| K092170 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K010963 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K082205 | GENETIC TESTING INSTITUTE |
20925 CROSSROADS CIRCLE | WAUKESHA | WI | 53186-4054 |
| K993553 | GENETIC TESTING INSTITUTE |
150 NORTH PATRICK BLVD. | BROOKFIELD | WI | 53045-5854 |
| K952668 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K952666 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K050448 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER, HERAULT | 34184 | |
| K050365 | HYPHEN BIOMED |
6560 GOVE CT. | MASON | OH | 45040 |
| K002467 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K981038 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K981817 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K974711 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K042576 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K070635 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K053499 | INSTRUMENTATION LABORATORY CO. |
526 RT. 303 | ORANGEBURG | NY | 10962 |
| K062430 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K102164 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K040843 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K133005 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K200033 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K223402 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K010379 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K981696 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K981200 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K011424 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K980875 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K992704 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K033631 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K955738 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K963106 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K962489 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K960438 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K023990 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K193204 | Precision BioLogic |
140 Eileen Stubbs Avenue | Dartmouth | B3B 0A9 | |
| K214002 | Precision BioLogic Inc. |
140 Eileen Stubbs Avenue | Dartmouth | B3B 0A9 | |
| K040987 | PRECISION BIOLOGIC INC. |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K043571 | PRECISION BIOLOGIC INC. |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K183440 | Precision BioLogic Inc. |
140 Eileen Stubbs Avenue | Dartmouth | B3B 0A9 | |
| K082631 | R2 DIAGNOSTICS, INC. |
1801 COMMERCE DR. | SOUTH BEND | IN | 46628 |
| K983107 | RAMCO LABORATORIES, INC. |
4507 MT.VERNON | HOUSTON | TX | 77006 |
| K972342 | REAADS MEDICAL PRODUCTS, INC. |
12001 TEJON ST. | WESTMINISTER | CO | 80234 |
| K972482 | REAADS MEDICAL PRODUCTS, INC. |
12061 TEJON ST. | WESTMINISTER | CO | 80234 |
| K972005 | REAADS MEDICAL PRODUCTS, INC. |
12061 TEJON ST. | WESTMINISTER | CO | 80234 |
| K980885 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K962825 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K000398 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K181525 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Strasse 76 | Marburg | 35041 | |
| K220728 | Siemens Healthcare Diagnostics Products GmbH |
Emil-von-Behring Strasse 76 | Marburg | 35041 | |
| K951640 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K002350 | THE GENETICS INSTITUTE |
87 CAMBRIDGE PARK DR. | CAMBRIDGE | MA | 02140-2387 |
| K961929 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K972288 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K964270 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K964459 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K973143 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
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