The following data is part of a premarket notification filed by Quantai Biotronics, Inc. with the FDA for Quantai Bg(tm) Reagent Strip.
| Device ID | K880703 |
| 510k Number | K880703 |
| Device Name: | QUANTAI BG(TM) REAGENT STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | QUANTAI BIOTRONICS, INC. 15405 RED HILL AVE., SUITE A Tustin, CA 92680 |
| Contact | Chen, Phd |
| Correspondent | Chen, Phd QUANTAI BIOTRONICS, INC. 15405 RED HILL AVE., SUITE A Tustin, CA 92680 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-07-08 |