FDA 510(k) Applications for Medical Device:
Hepatitis A Test (Antibody And Igm Antibody)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063329 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-6095 |
| K113704 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-6092 |
| K222850 | ABBOTT LABORATORIES |
100 Abbott Park Road | Abbott Park | IL | 60064 |
| K063318 | Bio-Rad Laboratories |
3 BD RAYMOND POINCARE | HAUTS-DE-SEINE | 92430 | |
| K063319 | Bio-Rad Laboratories |
3 BD RAYMOND POINCARE | HAUTS-DE-SEINE | 92430 | |
| K092355 | BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. | REDMOND | WA | 98052 |
| K092353 | BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. | REDMOND | WA | 98052 |
| K210272 | DiaSorin Inc. |
1951 Northwestern Ave | Stillwater | MN | 55082 |
| K193532 | DiaSorin Inc. |
1951 Northwestern Ave | Stillwater | MN | 55082 |
| K223403 | DiaSorin Inc. |
1951 Northwestern Ave. | Stillwater | MN | 55082 |
| K160650 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082-0285 |
| K082049 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K082050 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K141116 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K103529 | DIASORIN, INC. |
195 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K060770 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K060678 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K093955 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K190428 | Roche Diagnostics |
9115 Hague Road, PO Box 50416 | Indianapolis | IN | 46250 |
| K100903 | ROCHE PROFESSIONAL DIAGNOSTICS |
9115 HAGUE ROAD | INDIANAPOLIS | IN | |
| K081716 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K161964 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K142758 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
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