FDA 510(k) Applications for Medical Device:
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K092736 | EUROIMMUN US INC |
95 WASHINGTON ST | MORRISTOWN | NJ | 07960 |
| K971909 | HEMAGEN DIAGNOSTICS, INC. |
34-40 BEAR HILL RD. | WALTLHAM | MA | 02154 |
| K962452 | HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. | GARDEN GROVE | CA | 92841 |
| K163133 | IMMCO Diagnostics, Inc. |
9870 Hollingson Rd. | Clarence | NY | 14031 |
| K163525 | Inova Diagnostics, Inc. |
9900 Old Grove Road | San Diego | CA | 92131-1638 |
| K052262 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K181556 | Phadia AB |
Rapsgatan 7P | Uppsala | SE 754 50 | |
| K141375 | PHADIA US INC. |
MUNZINGER STRASSE 7 | FREIBURG IM BREISGAU | 79111 | |
| K031308 | RHIGENE, INC. |
12061 TEJON ST. | WESTMINSTER | CO | 80234 |
| K030238 | THE BINDING SITE, LTD. |
WEST TOWER, SUITE 4000 | SANTA MONICA | CA | 90404 |
| K982121 | TRACE SCIENTIFIC LTD. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
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