FDA 510(k) Applications for Medical Device:
Calprotectin, Fecal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K191807 | ALPCO |
26 Keewaydin Drive, Unit G | Salem | NH | 03079 |
| K220763 | ALPCO |
26-G Keewaydin Drive | Salem | NH | 03079 |
| K181012 | BUHLMANN Laboratories AG |
Baselstrasse 55 | Schonenbuch | CH-4124 | |
| K190784 | BUHLMANN Laboratories AG |
Baselstrasse 55 | Schonenbuch | 4124 | |
| K191718 | BUHLMANN Laboratories AG |
Baselstrasse 55 | Schonenbuch | 4124 | |
| K182698 | DiaSorin Inc. |
1951 Northwestern Ave. | Stillwater | MN | 55082-0285 |
| K213858 | DiaSorin Inc. |
1951 Northwestern Ave | Stillwater | MN | 55082 |
| K130945 | EUROSPITAL S.P.A. |
3331 EAGLE WATCH DRIVE | WOODSTOCK | GA | 30189 |
| K160447 | EUROSPITAL S.P.A. |
VIA FLAVIA 122 | TRIESTE | 34147 | |
| K191589 | Eurospital S.p.A. |
Via Flavia 122 | Trieste | 34147 | |
| K191592 | Eurospital S.p.A. |
Via Flavia 122 | Trieste | 34147 | |
| DEN060001 | GENOVA DIAGNOSTICS |
63 ZILLICOA ST. | ASHEVILLE | NC | 28801-1074 |
| K180971 | Inova Diagnostics, Inc. |
9900 Old Grove Road | San Diego | CA | 92131-1638 |
| K170993 | Inova Diagnostics, Inc. |
9900 Old Grove Road | San Diego | CA | 92131-1638 |
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