The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Helicobacter Pylori Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa)for The Detection Of Igg Antibodi.
| Device ID | K991820 |
| 510k Number | K991820 |
| Device Name: | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI |
| Classification | Helicobacter Pylori |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-27 |
| Decision Date | 1999-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028150 | K991820 | 000 |
| 04048474028157 | K991820 | 000 |