FDA 510(k) Applications for Medical Device:
Controls For Blood-Gases, (Assayed And Unassayed)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K002535 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K002120 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K003239 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K022529 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K003242 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K022525 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K002536 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K002866 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K002865 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K033063 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K152553 | EUROTROL B.V. |
KEPLERLAAN 20 | EDE | 6716 BS | |
| K961441 | INSTRUMENTARIUM CORP. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K972861 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K961355 | RADIOMETER AMERICA, INC. |
811 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K961354 | RADIOMETER AMERICA, INC. |
811 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K980135 | RADIOMETER AMERICA, INC. |
810 SHARON DR. | WESTLAKE | OH | 44145-1598 |
| K150226 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | ||
| K130415 | RADIOMETER MEDICAL APS |
AAKANDEVEJ 21 | BROENSHOEJ | DK-2700 | |
| K130236 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 |
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