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Ast/Sgot

by Derma Media Lab., Inc.

510(k) K965126

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK965126 Date17 Jan 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CIT
Device Class
Class II
Regulation
21 CFR Part 862.1100
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ast/Sgot is a device used to measure the activity of the enzyme aspartate amino transferase (Ast) (also known as serum glutamic oxaloacetic transferase or Sgot) in serum and plasma. It is a type of Nadh oxidation/Nad reduction device.

The Ast/Sgot device is supplied as a Class 2 Chemistry device with product code CIT and is cleared through the Traditional 510(k) pathway. It has an FDA 510(k) clearance, K965126, and is regulated under regulation number 862.1100. The device is intended for use in clinical chemistry settings.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ast/Sgot device used for?

    The Ast/Sgot device is used to measure the activity of the enzyme aspartate amino transferase in serum and plasma, which is useful in clinical chemistry settings.

  • How is the Ast/Sgot device supplied?

    The Ast/Sgot device is supplied as a Class 2 Chemistry device with product code CIT.

  • Is the Ast/Sgot device cleared by the FDA?

    Yes, the Ast/Sgot device has an FDA 510(k) clearance, K965126, and is regulated under regulation number 862.1100.

  • What type of settings is the Ast/Sgot device intended for?

    The Ast/Sgot device is intended for use in clinical chemistry settings.