STAT/LYTE Analyzer

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K771592 ↗

FDA Product Code

JFL

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the STAT/LYTE Analyzer used for?

  The STAT/LYTE Analyzer is a clinical chemistry device designed for pH rate measurement and carbon-dioxide analysis to provide laboratory testing capabilities for medical diagnostic purposes in clinical chemistry settings.

• How is the STAT/LYTE Analyzer supplied and what is its regulatory status?

  The STAT/LYTE Analyzer is supplied as a Class II medical device manufactured by Technicon Instruments Corp. It is authorized under FDA 510K clearance with K number K771592 and is regulated under product code JFL.

• What are the specifications of the STAT/LYTE Analyzer?

  The STAT/LYTE Analyzer is a clinical chemistry device with decision description of Substantially Equivalent and advisory committee description of Clinical Chemistry. It received FDA clearance on 1977-10-18 with decision code SESE and is manufactured in Mchenry, IL.

• Is the STAT/LYTE Analyzer reusable or single-use?

  The device data does not specify whether the STAT/LYTE Analyzer is reusable or single-use. For information regarding device reusability, please consult the manufacturer's instructions or contact Technicon Instruments Corp. directly.