FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K943843 | BIOWHITTAKER MOLECULAR APPLICATIONS, INC. |
8830 BIGGS FORD RD. | WALKERSVILLE | MD | 21793-0127 |
| K981867 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K231214 | DiaSorin Inc. |
1952 Northwestern Avenue | Stillwater | MN | 55082 |
| K150375 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082 |
| K061820 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K972295 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K984181 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K961012 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K070317 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K051484 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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