The following data is part of a premarket notification filed by Micro Detect, Inc. with the FDA for Elisa Test, Serology.
| Device ID | K003794 |
| 510k Number | K003794 |
| Device Name: | ELISA TEST, SEROLOGY |
| Classification | Helicobacter Pylori |
| Applicant | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 |
| Contact | Medhi Alem |
| Correspondent | Medhi Alem MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 Tustin, CA 92780 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-03-30 |