The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Glucose Reagent System.
| Device ID | K782136 |
| 510k Number | K782136 |
| Device Name: | GLUCOSE REAGENT SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | AMERICAN MONITOR CORP. 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 | 1978-12-27 |
| Decision Date | 1979-01-26 |