The following data is part of a premarket notification filed by Bio Scan Instrument, Inc. with the FDA for Bio Scan-bg(tm.
| Device ID | K910692 |
| 510k Number | K910692 |
| Device Name: | BIO SCAN-BG(TM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BIO SCAN INSTRUMENT, INC. 39W 32ND ST. New York, NY 10001 |
| Contact | Paul U Ju |
| Correspondent | Paul U Ju BIO SCAN INSTRUMENT, INC. 39W 32ND ST. New York, NY 10001 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-19 |
| Decision Date | 1991-03-29 |