The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi #24 & 24m Glucose Analyzers.
| Device ID | K821192 |
| 510k Number | K821192 |
| Device Name: | YSI #24 & 24M GLUCOSE ANALYZERS |
| Classification | Glucose Oxidase, Glucose |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-06-14 |