FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Cortisol, Salivary
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K051733 | DRG INTL., INC. |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K150528 | IBL INTERNATIONAL GMBH |
FLUGHAFENSTRASSE 52 A | HAMBURG | D-22335 | |
| K102841 | PANTEX, DIV. BIO-ANALYSIS, INC. |
1701 BERKELEY ST. | SANTA MONICA | CA | 90404 |
| K070788 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K043175 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K031348 | SALIMETRICS LLC. |
101 INNOVATION BLVD. | STATE COLLEGE | PA | 16803-6605 |
| K011323 | SALIMETRICS LLC. |
101 INNOVATION BLVD. | STATE COLLEGE | PA | 16803 |
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