The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Models 23c & 23cm Hdl & Total Choles.
| Device ID | K801285 |
| 510k Number | K801285 |
| Device Name: | YSI MODELS 23C & 23CM HDL & TOTAL CHOLES |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-29 |
| Decision Date | 1980-07-28 |