Biostator Glucose Analyzer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780393 ↗

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 Miles Laboratories, Inc. →

• What is the Biostator Glucose Analyzer used for?

  The Biostator Glucose Analyzer is designed for glucose analysis in clinical chemistry applications. It measures glucose levels in samples using glucose oxidase technology, providing accurate results for laboratory testing.

• Is the Biostator Glucose Analyzer single-use or reusable?

  The device is not specified as single-use or reusable in the provided information. This detail would need to be confirmed directly with the manufacturer, Miles Laboratories, Inc., for specific usage guidelines.

• What regulatory approvals does the Biostator Glucose Analyzer have?

  The Biostator Glucose Analyzer is classified as a Class II medical device with product code CGA. It received FDA 510(k) clearance on June 19, 1978, with regulation number 862.1345, and is substantially equivalent to other devices on the market.

• How is the Biostator Glucose Analyzer supplied?

  The device is supplied by Miles Laboratories, Inc. No specific information regarding packaging, quantities, or accessories is provided in the device data. Additional details would need to be obtained from the manufacturer.