The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Helicobacter Pylori Igg Elisa Test System.
| Device ID | K980821 |
| 510k Number | K980821 |
| Device Name: | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM |
| Classification | Helicobacter Pylori |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-07-30 |