FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Rubella
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K954318 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. D49C | ABBOTT PARK | IL | 60064-3500 |
| K243168 | Abbott Laboratories |
100 Abbott Park Road | Abbott Park | IL | 60064 |
| K954045 | ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K951541 | ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K003412 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K010668 | BAYER CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052-1688 |
| K951359 | BAYER CORP. |
8365 VALLEY PIKE | MIDDLETOWN | VA | 22645-0307 |
| K952721 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
P.O. BOX 987 | COLUMBUS | NE | 68602-0987 |
| K031606 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K092587 | Bio-Rad Laboratories |
5500 E. SECOND ST | BENICIA | CA | 94510 |
| K954687 | BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K080766 | BIOMERIEUX, INC. |
595 ANGLUM RD. | HAZELWOOD | MO | 63042 |
| K963613 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K012077 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K982078 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K001875 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K981729 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K093101 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K993291 | DIASORIN, INC. |
9175 GUIFORD RD. | COLUMBIA | MD | 21046 |
| K073390 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K122397 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K960367 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K960358 | INCSTAR CORP. |
1990 INDUSTRIAL BLVD. | STILLWATER | MN | 55082 |
| K971304 | INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K063143 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K961053 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K982281 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K092322 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K072617 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K063186 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K983805 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K984180 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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