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AST REAGENT

by Amresco, Inc.

510(k) K903829

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 NumberK903829 Date25 Sep 1990ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

AST REAGENT is a clinical chemistry reagent used for the measurement of aspartate aminotransferase (AST) or aspartate transaminase (SGOT) through NADH oxidation/NAD reduction method. This device is classified under product code CIT and is intended for use in clinical laboratory settings.

The AST REAGENT is manufactured by Amresco, Inc. and received FDA 510(k) clearance on September 25, 1990, with K number K903829. It is a Class II medical device regulated under 862.1100. The device is supplied in various sizes as indicated by the multiple registration numbers provided, though specific sterility and single-use or reusable status are not specified in the data.

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Questions

AI-generated answers, 23 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 clinical purpose does the AST REAGENT serve?

    The reagent is used in clinical laboratories to quantify aspartate aminotransferase (AST), also known as SGOT, by catalyzing the NADH oxidation/NAD reduction reaction. Measuring AST helps assess liver function and detect tissue damage, making the reagent essential for routine chemistry panels.

  • How is the AST REAGENT supplied and are multiple sizes available?

    Amresco distributes the AST REAGENT in several package sizes, each identified by a unique registration number in the FDA listing. While the exact volumes are not detailed in the data, the presence of many registration numbers indicates that laboratories can order the quantity that fits their testing volume and instrument requirements.

  • Is the AST REAGENT sterile or intended for single‑use?

    The FDA submission does not specify sterility or single‑use versus reusable status. Because it is a chemical reagent for in‑vitro analysis, it is typically supplied as a non‑sterile liquid that is used once per assay batch and then discarded according to laboratory safety protocols.

  • What regulatory pathway did the AST REAGENT follow?

    The product received traditional 510(k) clearance (K903829) on September 25 1990, indicating it was found substantially equivalent to a legally marketed predicate. It is classified as a Class II device under regulation 862.1100, product code CIT, and was reviewed by the Clinical Chemistry advisory committee.