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 |