FDA 510(k) Applications for Medical Device:
Counter, Cell, Automated (Particle Counter)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K152776 | Advanced Instruments, Inc. |
2 Technology Way | Norwood | MA | 02062 |
| K971998 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K954607 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K022331 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K051693 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K962988 | COULTER CORP. |
11800 S.W. 147TH AVE. | MIAMI | FL | 33196-2500 |
| K991070 | COULTER CORP. |
1950 WEST 8TH AVE. | HIALEAH | FL | 33010 |
| K071652 | HEMOCUE AB |
40 EMPIRE DRIVE | LAKE FOREST | CA | 92630 |
| K954006 | INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. | CHATSWORTH | CA | 91311 |
| K091539 | IRIS DIAGNOSTICS |
9172 ETON AVE. | CHATSWORTH | CA | 91311 |
| K050235 | IRIS INTERNATIONAL, INC. |
9172 ETON AVE. | CHATSWORTH | CA | 91311 |
| K032677 | SYSMEX AMERICA, INC. |
ONE NELSON C. WHITE PARKWAY | MUNDELEIN | IL | 60060 |
| K981761 | SYSMEX CORP. |
ONE WILDLIFE WAY | LONG GROVE | IL | 60047-9596 |
| K981950 | SYSMEX CORP. |
ONE WILDLIFE WAY | LONG GROVE | IL | 60047-9596 |
| K964375 | SYSMEX CORP. |
GILMER RD. | LONG GROVE | IL | 60047-9596 |
| K001683 | SYSMEX CORPORATION OF AMERICA |
ONE WILDLIFE WAY | LONG GROVE | IL | 60047-9596 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
