Lancer Msh Glucose Diag. Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K822958 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →

• What is the Lancer MSH Glucose Diagnostic Kit used for?

  The Lancer MSH Glucose Diagnostic Kit is a Class 2 chemistry device used for glucose diagnostic testing in clinical chemistry applications. It contains glucose oxidase and is designed for medical settings to measure glucose levels.

• Is the Lancer MSH Glucose Diagnostic Kit single-use or reusable?

  The Lancer MSH Glucose Diagnostic Kit is supplied as a single-use kit. This means it is designed for one-time use only and should not be reused for patient testing to ensure accurate results and maintain sterility.

• What are the storage requirements for the Lancer MSH Glucose Diagnostic Kit?

  The Lancer MSH Glucose Diagnostic Kit requires standard storage conditions. While specific temperature ranges aren't provided in the device data, it should be stored according to general medical device guidelines to maintain its integrity and effectiveness.

• What is the regulatory status of the Lancer MSH Glucose Diagnostic Kit?

  The Lancer MSH Glucose Diagnostic Kit received FDA 510(k) clearance with number K822958 on November 5, 1982. It is regulated under product code CGA with regulation number 862.1345, indicating it is substantially equivalent to other marketed devices.