The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Pylori Igg Elisa Test System.
| Device ID | K961221 |
| 510k Number | K961221 |
| Device Name: | PYLORI IGG ELISA TEST SYSTEM |
| Classification | Helicobacter Pylori |
| Applicant | ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler |
| Correspondent | William L Boteler ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-07-30 |
| Summary: | summary |