The following data is part of a premarket notification filed by Ysis, Inc with the FDA for Ysi Model 2300 Stat Plus.
| Device ID | K913806 |
| 510k Number | K913806 |
| Device Name: | YSI MODEL 2300 STAT PLUS |
| Classification | Glucose Oxidase, Glucose |
| Applicant | YSIS, INC 1725 BRANNUM LN. Yellow Springs, OH 45387 -0279 |
| Contact | Fred Breidt |
| Correspondent | Fred Breidt YSIS, INC 1725 BRANNUM LN. Yellow Springs, OH 45387 -0279 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-10-02 |