Skip to content

Raichem Spia Apo B Reagents

by Reagents Applications, Inc. 510(k)

Active United States

510(k) K872080

Overview

Raichem Spia Apo B Reagents are a lipoprotein, low-density, antigen, antiserum, and control device. These reagents are used for the detection and measurement of specific antigens in laboratory testing.

This device is authorized under FDA 510(k) clearance K872080. It is manufactured by Reagents Applications, Inc. and is classified under regulation number 866.5600.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872080 Date15 Jun 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Raichem(Tm) Spia(Tm) Apo B Reagents
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

Other devices from Reagents Applications, Inc.

See all devices from Reagents Applications, Inc. →

Questions

  • What is the primary use of Raichem Spia Apo B Reagents?

    These reagents are designed for the detection and measurement of specific antigens within a laboratory setting. They function as a lipoprotein, low-density, antigen, antiserum, and control device.

  • Is this device authorized for use?

    Yes, the Raichem Spia Apo B Reagents are authorized under FDA 510(k) clearance, specifically documented under K872080.

  • How is this device classified for regulatory purposes?

    The device is classified under regulation number 866.5600, which pertains to lipoprotein, low-density, antigen, antiserum, and control devices used in clinical immunology.