FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K153730 | Abbott Laboratories |
Dept 09AA, Bldg. AP 8, | Abbott Park | IL | 60064-6038 |
| K063866 | Bio-Rad Laboratories |
6565 185TH AVE, NE | REDMOND | WA | 98052 |
| K170413 | Bio-Rad Laboratories |
5500 E. 2nd Street | Benicia | CA | 94510 |
| K120439 | BIO-RAD LABORATORIES, INC. |
5500 EAST 2ND ST. | BENICIA | CA | 94510 |
| K102400 | DIAGNOSTICS DIRECT, LLC. |
150 CHERRY LANE RD | EAST STROUDSBURG | PA | 18301 |
| K992552 | DIASORIN, INC. |
9175 GUIFORD RD. | COLUMBIA | MD | 21046 |
| K061247 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K050590 | DIESSE DIAGNOSTICA SENESE S.P.A |
555 NE 34TH ST #1905 | MIAMI | FL | 33137 |
| K153145 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K053570 | PHOENIX BIOTECH CORP. |
150 CHERRY LANE ROAD | EAST STROUDSBURG | PA | 18301 |
| K001552 | PHOENIX BIOTECH CORP. |
53 CEDAR LAKE RD. | BLAIRSTOWN | NJ | 07825 |
| K960493 | PYRAMID BIOLOGICAL CORP. |
6454 VAN NUYS BLVD., SUITE 111 | VAN NUYS | CA | 91401 |
| K961317 | PYRAMID BIOLOGICAL CORP. |
6454 VAN NUYS BLVD., SUITE 111 | VAN NUYS | CA | 91401 |
| K160910 | ROCHE DIAGNOSTICS |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250 |
| K211302 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K091361 | SIEMENS HEALTHCARE DIAGNOSTICS |
6695 RIVER CREST POINT | SUWANEE | GA | 30024 |
| K112343 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |
| K001525 | TRINITY BIOTECH, PLC |
PO BOX 1059, 2823 GIRTS RD. | JAMESTOWN | NY | 14702-1059 |
| K014233 | TRINITY BIOTECH, PLC |
IDA BUSINESS PARK BRAY | CO. WICKLOW | ||
| K102283 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K093837 | ZEUS SCIENTIFIC, INC. (ZEUS) |
P.O. BOX 38 | RARITAN | NJ | 08869 |
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