The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for 6% Ortho Loliudine Reagent In Glacid Aci.
| Device ID | K810089 |
| 510k Number | K810089 |
| Device Name: | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI |
| Classification | Orthotoluidine, Glucose |
| Applicant | ANCO MEDICAL REAGENTS & ASSOC. 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 | 1981-01-13 |
| Decision Date | 1981-01-26 |