STA Automated Multi-Parametric Analyzer

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

510(k) Number

K942117 ↗

FDA Product Code

GKP

Device Class

Class II

Regulation

21 CFR Part 864.5400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the STA Automated Multi-Parametric Analyzer used for?

  The STA Automated Multi-Parametric Analyzer is an automated instrument designed for coagulation testing in laboratory settings. It performs multiple parameter analysis to assist in diagnosing and monitoring coagulation disorders.

• Is the STA analyzer single-use or reusable?

  The provided data does not specify whether the STA Automated Multi-Parametric Analyzer is single-use or reusable. It is supplied as a Class II medical device intended for laboratory use, but specific usage instructions regarding reusability are not included in the information provided.

• What regulatory approvals does the STA analyzer have?

  The STA Automated Multi-Parametric Analyzer has FDA 510(k) clearance, which means it has been determined to be substantially equivalent to existing devices. It is classified as a Class II medical device and is intended for laboratory use only.

• What are the specifications of the STA analyzer?

  The STA analyzer is manufactured by American Bioproducts Co. and is designed for multiple parameter coagulation testing. It has a product code of GKP and is reviewed by the Hematology advisory committee. The device is not specified as single-use or reusable in the provided data.