FDA 510(k) Applications for Medical Device:
Device, Automated Cell-Locating
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964689 | ACCUMED INTL., INC. |
900 NO. FRANKLIN | CHICAGO | IL | 60610 |
| K982786 | ACCUMED INTL., INC. |
900 NO. FRANKLIN | CHICAGO | IL | 60610 |
| K001420 | APPLIED IMAGING CORP. |
2380 WALSH AVE., BLDG.B | SANTA CLARA | CA | 95051 |
| K980375 | APPLIED IMAGING CORP. |
2380 WALSH AVE., BLDG.B | SANTA CLARA | CA | 95051 |
| K071398 | APPLIED SPECTRAL IMAGING, LTD. |
HAMATECHET ST 4. | RAMAT GAVRIEL | 10551 | |
| K030192 | BIOVIEW LTD. |
117 AHUZAH ST. | RA'ANANNA | 76703 | |
| K040591 | BIOVIEW LTD. |
12 HAMADA ST. | REHOVOT | 76703 | |
| K061602 | BIOVIEW LTD. |
7 JABOTINSKY ST. | RAMAT GAN | 52520 | |
| K050840 | BIOVIEW LTD. |
11 MENACHEM BEGIN ST. | RAMAT-GAN | 52521 | |
| K171315 | Cella Vision AB |
Ideon Science Park | Lund | SE-223 70 | |
| K200595 | CellaVision AB |
Mobilvagen 12 | Lund | 22362 | |
| K092868 | CELLAVISION AB |
435 RICE CREEK TERRACE NE | FRIDLEY | MN | 55432 |
| K102778 | CELLAVISION AB |
435 RICE CREEK TERRACE NE | FRIDLEY | MN | 55432 |
| K033840 | CELLAVISION AB |
6740 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K080595 | CELLAVISION AB |
6740 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K003301 | CELLAVISION AB |
6740 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K984188 | CHROMAVISION MEDICAL SYSTEMS, INC. |
3535 FIREWHEEL DR. | FLOWER MOUND | TX | 75028-2628 |
| K052577 | IKONISYS INC |
5 SCIENCE PARK | NEW HAVEN | CT | 06511 |
| K061392 | IKONISYS INC |
5 SCIENCE PARK | NEW HAVEN | CT | 06511 |
| K062755 | IKONISYS INC |
5 SCIENCE PARK | NEW HAVEN | CT | 06511 |
| K092116 | MEDICA CORP. |
163 CABOT STREET | BEVERLY | MA | 01915 |
| K201301 | Scopio Labs LTD. |
11 Tiomkin St., 2nd floor | Tel Aviv | 6578313 | |
| K243144 | Scopio Labs Ltd. |
10 Hasharon Street | Tel Aviv | 6618502 | |
| K220013 | Scopio Labs Ltd. |
10 HaSharon | Tel Aviv | 6618502 | |
| K970824 | SHOTWELL & CARR, INC. |
3003 LBJ FREEWAY, SUITE 100 | DALLAS | TX | 75234-7755 |
| K221309 | SigTuple Technologies Pvt. Ltd. |
First Floor, L-162, 14th Cross Road, Sector 6, HSR Layout | Bangalore | 560102 | |
| K182062 | Sysmex America, Inc. |
577 Aptakisic Road | Lincolnshire | IL | 60069 |
| K960774 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD. | PALM BEACH GARDENS | FL | 33410 |
| K971470 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD. | PALM BEACH GARDENS | FL | 33410 |
| K960776 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD. | PALM BEACH GARDENS | FL | 33410 |
| K982301 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD., #214 | PALM BEACH GARDENS | FL | 33410 |
| K973050 | TRIANGLE BIOMEDICAL SCIENCES, INC. |
4360 NORTHLAKE BLVD., #100 | PALM BEACH GARDENS | FL | 33410 |
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