6% Ortho Loliudine Reagent in Glacid Aci
by Anco Medical Reagents & Assoc.
510(k) K810089
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810089 | Date26 Jan 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGE
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
This device is a 6% Ortho Loliudine Reagent in Glacid Aci, classified as a medical device under device class 2 with the device name Orthotoluidine, Glucose, and medical specialty description Clinical Chemistry. It is identified by the product code CGE and regulation number 862.1345. The reagent is substantially equivalent to a legally marketed device, as determined by FDA 510(k) clearance K810089.
It is supplied by Anco Medical Reagents & Assoc. located in Mchenry, Illinois, US. The device received FDA 510(k) clearance on January 26, 1981, following a traditional review process, and is authorized for distribution in the United States. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or clinical indications is provided in the data.
Other devices from Anco Medical Reagents & Assoc.
Questions
AI-generated answers, 6 Oct 2026
What is the 6% Ortho Loliudine Reagent in Glacid Aci used for?
This reagent is used in clinical chemistry applications, specifically for glucose and orthotoluidine testing, as indicated by its device name and medical specialty description in the FDA 510(k) clearance.
How is the 6% Ortho Loliudine Reagent in Glacid Aci supplied and by whom?
The reagent is supplied by Anco Medical Reagents & Assoc., located at 803 N. Front St. Suite 3, Mchenry, Illinois, 60050, United States, as stated in the device authorization data.
What regulatory clearance does the 6% Ortho Loliudine Reagent in Glacid Aci have?
It has FDA 510(k) clearance under number K810089, granted on January 26, 1981, following a traditional review process, and is classified as substantially equivalent to a legally marketed device.