FDA 510(k) Applications for Medical Device:
Activated Whole Blood Clotting Time
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964609 | ARRAY MEDICAL, INC. |
245 RT. 22 WEST | BRIDGEWATER | NJ | 08807 |
| K983649 | ARRAY MEDICAL, INC. |
ONE HARVARD WAY, SUITE 5 | SOMERVILLE | NJ | 08876 |
| K971935 | B & D CORP. |
14 MICHAEL DR. | METUCHEN | NJ | 08840 |
| K994194 | CARDIOVASCULAR DIAGNOSTICS, INC. |
5301 DEPARTURE DR. | RALEIGH | NC | 27616 |
| K062604 | HAEMOSCOPE CORP. |
6231 W. HOWARD ST. | NILES | IL | 60714 |
| K013078 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K020914 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K992571 | I-STAT CORP. |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K023582 | I-STAT CORPORATION |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K960749 | INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. | EDISON | NJ | 08820 |
| K992851 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K032952 | SIENCO, INC. |
11485-A WEST 48TH AVE. | WHEAT RIDGE | CO | 80033 |
| K984141 | SIENCO, INC. |
4892 VAN GORDON ST., UNIT 203 | WHEATRIDGE | CO | 80033 |
| K002528 | SIENCO, INC. |
11485-A WEST 48TH AVE. | WHEAT RIDGE | CO | 80033 |
| K223635 | Sienco, Inc. |
5721 Arapahoe Ave, Unit A1-A | Boulder | CO | 80303 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
