Skip to content

Resubmitted Abbott Testpack HCG Combo

by Abbott Laboratories 510(k)

Active United States

510(k) K884207

Overview

The Resubmitted Abbott Testpack HCG Combo is a Class 2 Chemistry device designed for testing Human Chorionic Gonadotropin (HCG). It is a system used for clinical chemistry applications to detect HCG levels.

This device is manufactured by Abbott Laboratories and was cleared through the Traditional 510(k) pathway on December 2, 1988, after a 57-day FDA review. It is regulated under 862.1155 and has the product code DHA. The device is supplied as a system for clinical chemistry testing.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884207 Date2 Dec 1988ClearedStatusActive

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: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

Full name
Resubmitted Abbott Testpack(Tm) Hcg Combo
510(k) Number
FDA Product Code
DHA
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Questions

  • What is the Abbott Testpack HCG Combo used for?

    The Abbott Testpack HCG Combo is a Class 2 Chemistry device designed for testing Human Chorionic Gonadotropin (HCG) levels. It is used in clinical chemistry applications to detect HCG levels in patients.

  • How is the Abbott Testpack HCG Combo supplied?

    The device is supplied as a complete system for clinical chemistry testing. It includes all necessary components for detecting HCG levels in a clinical laboratory setting.

  • What is the regulatory status of the Abbott Testpack HCG Combo?

    The Abbott Testpack HCG Combo was cleared through the Traditional 510(k) pathway on December 2, 1988, after a 57-day FDA review. It is regulated under product code DHA and regulation number 862.1155.

  • Is the Abbott Testpack HCG Combo a single-use device?

    The device data does not specify whether the Abbott Testpack HCG Combo is designed for single-use or multiple uses. The information provided focuses on its regulatory classification and purpose rather than its usage specifications.