FDA 510(k) Applications for Medical Device:
Colorimetry, Cholinesterase
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001344 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K013750 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K103373 | BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD | BREA | CA | 92821 |
| K002792 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K955498 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K961656 | EQM RESEARCH, INC. |
2585 MONTANA AVE. | CINCINNATI | OH | 45211 |
| K943367 | INSTRUMENTATION LABORATORY CO. |
101 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K030045 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K061093 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K051444 | SENTINEL CH. SRL |
5 VIA PRINCIPE EUGENIO | MILANO | 20155 | |
| K023992 | WIENER LABORATORIES S.A.I.C. |
2571 MAIPU | ROSARIO, SANTA FE | 2000 |
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