Glucose Reagent
by Ac Biochemical Laboratories, Inc.
510(k) K823537
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823537 | Date6 Apr 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
Glucose Reagent is a chemical reagent used for the quantitation of glucose levels in various body fluids. It is an aldohexose with four chiral carbon atoms, typically obtained from starch hydrolyzed by acid and/or enzymes. The reagent is used in diagnostic assays to aid in diabetes diagnosis and treatment.
The Glucose Reagent is supplied as a chemical reagent and is used in laboratory settings. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code FMF and authorization number K823537.
Other devices from Ac Biochemical Laboratories, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Glucose Reagent used for?
The Glucose Reagent is a chemical reagent used for the quantitation of glucose levels in various body fluids. It is primarily used in diagnostic assays to aid in diabetes diagnosis and treatment.
How is the Glucose Reagent supplied?
The Glucose Reagent is supplied as a chemical reagent for use in laboratory settings. No specific information is provided regarding whether it is single-use or reusable.
What is the regulatory status of the Glucose Reagent?
The Glucose Reagent has FDA 510(k) clearance with product code FMF and authorization number K823537. It was determined to be substantially equivalent to predicate devices.
What is the composition of the Glucose Reagent?
The Glucose Reagent is an aldohexose with four chiral carbon atoms, typically obtained from starch hydrolyzed by acid and/or enzymes. It is formulated specifically for diagnostic laboratory use.