The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Reagent, Glucose, Flow-through Analyzer.
| Device ID | K760055 |
| 510k Number | K760055 |
| Device Name: | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER |
| Classification | Hexokinase, Glucose |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-16 |
| Decision Date | 1976-08-26 |