The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zorba(tm) Igg Removal Reagent.
| Device ID | K924197 |
| 510k Number | K924197 |
| Device Name: | ZORBA(TM) IGG REMOVAL REAGENT |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Joseph A Rosebrock |
| Correspondent | Joseph A Rosebrock ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1992-12-15 |