Skip to content

Fastep S10 Hcg Serum/Urine Combo Test

by Polymed Therapeutics, Inc. 510(k)

Active United States

510(k) K132834

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132834 Date9 Jan 2014ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 FASTEP S10 HCG SERUM/URINE COMBO TEST is a lateral flow chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum. It utilizes a strip or cassette format containing a membrane pre-coated with goat anti-hCG polyclonal antibody and an antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody).

The device is intended for prescription use and is classified as FDA Class 2 under regulation number 862.1155, with product code JHI. It received traditional 510(k) clearance (K132834) on January 9, 2014, following a 121-day review, and was found substantially equivalent to a legally marketed predicate device. The test is supplied in a non-sterile, single-use format for use in clinical laboratory or point-of-care settings.

Other devices from Polymed Therapeutics, Inc.