FDA 510(k) Applications for Medical Device:
Plasma, Coagulation Factor Deficient
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K962675 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K962671 | AMERICAN BIOPRODUCTS CO. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K981709 | DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K040362 | DIAPHARMA GROUP, INC. |
8948 BECKETT RD. | WEST CHESTER | OH | 45069 |
| K050661 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K031829 | INSTRUMENTATION LABORATORY CO. |
526 RT. 303 | ORANGEBURG | NY | 10962 |
| K023839 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K024082 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K034007 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K110237 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K031122 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K030287 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K043459 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K180486 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K972627 | PACIFIC HEMOSTASIS |
11515 VANSTORY DR. | HUNTERSVILLE | NC | 28078-8144 |
| K990046 | PACIFIC HEMOSTASIS |
11515 VANSTORY DR. | HUNTERSVILLE | NC | 28078-8144 |
| K990814 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K990296 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K222831 | Precision BioLogic Inc. |
140 Eileen Stubbs Avenue | Dartmouth | B3B 0A9 | |
| K971226 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K971223 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K971224 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K971225 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K971227 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K981173 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K981174 | PRECISION BIOLOGICALS, INC. |
900 WINDMILL ROAD | DARTMOUTH, NOVA SCOTIA | B3B 1P7 | |
| K102908 | R2 DIAGNOSTICS, INC. |
1801 COMMERCE DR. | SOUTH BEND | IN | 46628 |
| K102851 | R2 DIAGNOSTICS, INC. |
1801 COMMERCE DR. | SOUTH BEND | IN | 46628 |
| K972286 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K970607 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
| K970593 | UNIVERSAL REAGENTS, INC. |
2858 N. PENNSYLVANIA ST. | INDIANAPOLIS | IN | 46205 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
