The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Glucose-o Test.
| Device ID | K811883 |
| 510k Number | K811883 |
| Device Name: | KING DIAGNOSTICS GLUCOSE-O TEST |
| Classification | Orthotoluidine, Glucose |
| Applicant | KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-23 |