The following data is part of a premarket notification filed by Micro Detect, Inc. with the FDA for Pylori Detect Igg.
| Device ID | K973508 |
| 510k Number | K973508 |
| Device Name: | PYLORI DETECT IGG |
| Classification | Helicobacter Pylori |
| Applicant | MICRO DETECT, INC. 23016 DEL LAGO DR., SUITE B Laguna Hills, CA 92653 |
| Contact | Mehdi Alem Ph.d. |
| Correspondent | Mehdi Alem Ph.d. MICRO DETECT, INC. 23016 DEL LAGO DR., SUITE B Laguna Hills, CA 92653 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1998-03-10 |
| Summary: | summary |