FDA 510(k) Applications for Medical Device:
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971464 | EURO-DIAGNOSTICA AB |
155 CIDER MILL RD. | RINGOES | NJ | 08551 |
| K180202 | Immuno Concepts, NA, Ltd. |
9825 Goethe Rd., Suite 350 | Sacramento | CA | 95827 |
| K980312 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K971658 | JAY H. GELLER |
2425 WEST OLYMPIC BLVD. | SANTA MONICA | CA | 90404 |
| K953495 | SCIMEDX CORP. |
400 FORD RD. | DENVILLE | NJ | 07834 |
| K963525 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K955431 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K974169 | WIESLAB AB |
1306 BAILES LN. | FREDERICK | MD | 21701 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
