FDA 510(k) Applications for Medical Device:
Antibody Igm, If, Epstein-Barr Virus
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123021 | Bio-Rad Laboratories |
5500 SECOND ST | BENICIA | CA | 94510 |
| K991459 | DIASORIN, INC. |
9175 GUIFORD RD. | COLUMBIA | MD | 21046 |
| K073381 | FOCUS DIAGNOSTICS, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K973939 | GenBio |
15222 AVE. OF SCIENCE, SUITE A | SAN DIEGO | CA | 92128 |
| K033780 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K990977 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K042092 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
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