FDA 510(k) Applications for Medical Device:
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K153551 | Axis-Shield Diagnostics Limited. |
The Technology Park | Dundee | DD2 1XA | |
| K083868 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K110296 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K063347 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K023285 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K021516 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K093954 | Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION | BENICIA | CA | 94510 |
| K112810 | Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION | BENICIA | CA | 94510 |
| K093908 | EURO-DIAGNOSTICA AB |
1129 BLOOMFIELD AVENUE | WEST CALDWELL | NJ | 07006 |
| K062045 | EURO-DIAGNOSTICA AB |
MEDEON | MALMO | SE-205 12 | |
| K091657 | EURO-DIAGNOSTICA AB |
LUNDAVAGEN 151 | MALMO | SE-212 24 | |
| K052133 | EURODIAGNOSTICA |
1306 BAILES LANE, SUITE F | FREDERICK | MD | 21701 |
| K070789 | EUROIMMUN US LLC |
429 ROCKAWAY VALLEY RD. | BOONTON | NJ | 07005 |
| K143754 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE ROAD | SAN DIEGO | CA | 92131 |
| K020414 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K052264 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K072944 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K081338 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K121576 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K061165 | SWEDEN DIAGNOSTICS (US), INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K090753 | THERATEST LABORATORIES, INC. |
1111 N. MAIN ST. | LOMBARD | IL | 60148 |
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