The following data is part of a premarket notification filed by Medmira Laboratories, Inc. with the FDA for Medmira Rapid H. Pylori Antibody Test, Model 10714.
| Device ID | K002023 |
| 510k Number | K002023 |
| Device Name: | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 |
| Classification | Helicobacter Pylori |
| Applicant | MEDMIRA LABORATORIES, INC. 155 CHAIN LAKE DR. Halifax, N.s., CA B3s 1b3 |
| Contact | Todd Bishop |
| Correspondent | Todd Bishop MEDMIRA LABORATORIES, INC. 155 CHAIN LAKE DR. Halifax, N.s., CA B3s 1b3 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-11-13 |