FDA 510(k) Applications for Medical Device:
Antibodies, Gliadin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K132082 | AESKU.DIAGNOSTICS |
MIKROFORUM RING 2 | WENDELSHEIM | D-55234 | |
| K052439 | AESKU.DIAGNOSTICS |
8880 NW 18TH TERRACE | MIAMI | FL | 33172 |
| K053383 | BIOMEDICAL DIAGNOSTICS (BMD) SA |
ACTIPOLE 25 | MARNE LA VALLEE CEDEX 2 | 77435 | |
| K041002 | BIOMEDICAL DIAGNOSTICS S.A. |
ACTIPOLE, 25-BD DE BEAUBOURG | MARNE-LA-VALLEE, CEDEX 2 | 77423 | |
| K993086 | COGENT DIAGNOTICS LTD. |
PENTLANDS SCIENCE PARK | MIDLOTHIAN, SCOTLAND | EH26 OPL | |
| K993087 | COGENT DIAGNOTICS LTD. |
PENTLANDS SCIENCE PARK | MIDLOTHIAN, SCOTLAND | EH26 OPL | |
| K012797 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K012795 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K083052 | EUROIMMUN US INC |
95 WASHINGTON ST | MORRISTOWN | NJ | 07960 |
| K083053 | EUROIMMUN US INC |
95 WASHINGTON ST | MORRISTOWN | NJ | 07960 |
| K973910 | GENESIS DIAGNOSTICS LTD. |
EDEN RESEARCH PARK | LITTLEPORT, CAMBRIDGESHIRE | CB6 1SE | |
| K113377 | GRIFOLS USA, LLC |
2410 LILLYVALE AVE. | LOS ANGELES | CA | 90032 |
| K964341 | IMMCO DIAGNOSTICS, INC. |
963 KENMORE AVE. | BUFFALO | NY | 14223 |
| K964344 | IMMCO DIAGNOSTICS, INC. |
963 KENMORE AVE. | BUFFALO | NY | 14223 |
| K091522 | IMMCO DIAGNOSTICS, INC. |
60 PINEVIEW DR. | BUFFALO | NY | 14228-2120 |
| K163177 | IMMCO DIAGNOSTICS, INC. |
9870 Hollingson Rd | Clarence | NY | 14031 |
| K111414 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K113863 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K062708 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K052143 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K052142 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K070083 | INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. | SAN DIEGO | CA | 92131-1638 |
| K964986 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K964985 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K002358 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780-7033 |
| K002359 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780-7033 |
| K093459 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K063775 | PHADIA US INC. |
4169 COMMERCIAL AVE. | PORTAGE | MI | 49002 |
| K982533 | PHARMACIA & UPJOHN CO. |
7000 PORTAGE RD. | KALAMAZOO | MI | 49001 |
| K982701 | PHARMACIA & UPJOHN CO. |
7000 PORTAGE RD. | KALAMAZOO | MI | 49001 |
| K052793 | PHARMACIA DIAGNOSTICS AB |
4169 COMMERCIAL AVENUE | PORTAGE | MI | 49002 |
| K002169 | SCIMEDX CORP. |
400 FORD RD. | DENVILLE | NJ | 07834 |
| K002189 | SCIMEDX CORP. |
400 FORD RD. | DENVILLE | NJ | 07834 |
| K041354 | SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MUNZINGER STRASSE 7 | FREIBURG | D-79111 | |
| K041357 | SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MUNZINGER STRASSE 7 | FREIBURG | D-79111 | |
| K981644 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K981929 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K081674 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K990207 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K990204 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K993250 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K001393 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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