FDA 510(k) Applications for Medical Device:
Fibrin Split Products
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K993276 | AGEN BIOMEDICAL LTD. |
7 & 11 DURBELL ST., | BRISBANE, QUEENSLAND | 4110 | |
| K972316 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K021877 | BIOMERIEUX, INC. |
100 RODOLPHE ST | DURHAM | NC | 27712 |
| K042890 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K112120 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K072288 | MITSUBISHI KAGAKU IATRON |
701 FIFTH AVENUE | SEATTLE | WA | 98104 |
| K070453 | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
3131 WEST ROYAL LANE | IRVING | TX | 75063-3104 |
| K030740 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K062203 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K011143 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
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