The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Varicella-zoster(igg) Ifa Test.
| Device ID | K841434 |
| 510k Number | K841434 |
| Device Name: | VARICELLA-ZOSTER(IGG) IFA TEST |
| Classification | Antigen, Cf, (including Cf Control), Varicella-zoster |
| Applicant | ZEUS SCIENTIFIC, INC. ST. JOHN & ELIZABETH STREETS Raritan , NJ 08869 - |
| Contact | David A Wall |
| Correspondent | David A Wall ZEUS SCIENTIFIC, INC. ST. JOHN & ELIZABETH STREETS Raritan , NJ 08869 - |
| Product Code | GQW |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-06 |
| Decision Date | 1985-04-19 |