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Lipoprotein (A) SPQ III Antibody Reagent Set

by Diasorin/American Standard Companies

510(k) K994110

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK994110 Date21 Dec 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DFC
Device Class
Class II
Regulation
21 CFR Part 866.5600
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Lipoprotein (A) SPQ III Antibody Reagent Set is an in vitro diagnostic device designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum or plasma. This device is classified as a lipoprotein, low-density, antigen, antiserum, control and is part of the SPQ test system.

The device is supplied as a reagent set and is intended for laboratory use. It has received FDA 510(k) clearance with the product code DFC and is classified under Class II with Special Controls. The device is manufactured by Diasorin/American Standard Companies and is authorized for in vitro diagnostic use.

Questions

AI-generated answers, 26 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 Lipoprotein (A) SPQ III Antibody Reagent Set used for?

    This in vitro diagnostic device is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum or plasma. It is part of the SPQ test system and intended for laboratory use only.

  • How is the Lipoprotein (A) SPQ III Antibody Reagent Set supplied?

    The device is supplied as a reagent set. It is manufactured by Diasorin/American Standard Companies and is authorized for in vitro diagnostic use in laboratory settings.

  • What is the regulatory status of this device?

    The Lipoprotein (A) SPQ III Antibody Reagent Set has received FDA 510(k) clearance with the product code DFC. It is classified under Class II with Special Controls and is authorized for in vitro diagnostic use.

  • What are the specifications of this reagent set?

    This device is classified as a lipoprotein, low-density, antigen, antiserum, control. It is part of the SPQ test system and is intended for quantitative determination of human lipoprotein(a) in serum or plasma samples.