FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K954301 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. D49C | ABBOTT PARK | IL | 60064-3500 |
| K220949 | Abbott Laboratories |
Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. | Abbott Park | IL | 60064 |
| K953943 | ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K963084 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K993952 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K950672 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K981163 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K162969 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082-0285 |
| K040290 | DIASORIN S.P.A. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K982027 | DIASORIN, INC. |
9175 GUIFORD RD. | COLUMBIA | MD | 21046 |
| K944438 | HEMAGEN DIAGNOSTICS, INC. |
34 BEAR HILL RD. | WALTHAM | MA | 02154 |
| K955361 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K955360 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K960434 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K971335 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K954191 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K982485 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K220911 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K163569 | Roche Diagnostics |
9115 Hague Rd. | Indianapolis | IN | 46250 |
| K131605 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K142133 | Roche Diagnostics |
9155 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K181213 | Siemens Healthcare Diagnostics, Inc. |
511 Benedict Ave | Tarrytown | NY | 10591 |
| K984139 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K983803 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
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