The following data is part of a premarket notification filed by Yellow Springs Instrument Co., Inc. with the FDA for Ysi Model 1500 Blood Glucose Analyzer.
| Device ID | K910633 |
| 510k Number | K910633 |
| Device Name: | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Contact | Fred Breidt |
| Correspondent | Fred Breidt YELLOW SPRINGS INSTRUMENT CO., INC. 1725 BRANNUM LN. Yellow Springs, OH 45387 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-04-12 |