The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Glucose Auto& Stat Ga-1120.
| Device ID | K843003 |
| 510k Number | K843003 |
| Device Name: | GLUCOSE AUTO& STAT GA-1120 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | KYOTO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-09-28 |