FDA 510(k) Applications for Medical Device:
Activated Partial Thromboplastin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K961892 | ANALYTICAL CONTROL SYSTEMS, INC. |
9058 TECHNOLOGY DR. | FISHERS | IN | 46038 |
| K955450 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K014028 | CARESIDE HEMOTOLOGY, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K053111 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K050221 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K160445 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730-2442 |
| K060688 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K973306 | INSTRUMENTATION LABORATORY CO. |
526 RT. 303 | ORANGEBURG | NY | 10962 |
| K972831 | INTERNATIONAL TECHNIDYNE CORP. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K014008 | ITC, INC. |
8 OLSEN AVE. | EDISON | NJ | 08820 |
| K955638 | ORTHO DIAGNOSTIC SYSTEMS, INC. |
1001 U.S. HIGHWAY 202 | RARITAN | NJ | 08869-0606 |
| K193556 | Precision BioLogic |
140 Eileen Stubbs Avenue | Dartmouth | B3B 0A9 | |
| K992711 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K992712 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K022021 | VITAL SCIENTIFIC N.V. |
ONE GATEWAY CENTER SUITE 411 | NEWTON | MA | 02458 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
