Visual Serum/Urine HCG Combo Kit

FDA 510(k) K852437 · American Bioclinical, Inc.

Substantially Equivalent

510(k) numberK852437

Submission

Device name
Visual Serum/Urine HCG Combo Kit
Applicant
American Bioclinical, Inc.
Portland, OR, US
Received
June 10, 1985
Decision date
July 12, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JHI – Visual, Pregnancy Hcg, Prescription Use
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1155
Specialty
Clinical Chemistry

Other 510(k)s with product code JHI

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K241919Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional Innovita (Tangshan) Biological Technology Co.…08/02/2024SE
K203272Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional Hangzhou AllTest Biotech Co., Ltd.01/31/2022SE
K172322Atellica IM Total hCG (ThCG)JHI · Traditional Siemens Healthcare Diagnostics, Inc.03/29/2018SE
K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional True Diagnostics, Inc.12/22/2017SE
K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional Assure Tech. Co., Ltd.02/24/2016SE
K130456Wunder Pregnancy TestJHI · Traditional James Nguyen04/08/2014SE
K132834Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional Polymed Therapeutics, Inc.01/09/2014SE
K131166Sofia(R) HCG FiaJHI · Traditional Quidel Corp.08/02/2013SE
K123844Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional Chemtron Biotech, Inc.05/30/2013SE
K112101Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional Polymed Therapeutics, Inc.07/17/2012SE

More from Polymed Therapeutics, Inc.

510(k)DeviceDecision
K852939Cortisol System by EiaCGR · Traditional 08/02/1985SE
K852376Simultaneous Lh/Fsh System by RiaCEP · Traditional 07/09/1985SE
K851330Prolactin System by RiaCFT · Traditional 04/29/1985SE

Questions and answers

When was Visual Serum/Urine HCG Combo Kit cleared by the FDA?

Visual Serum/Urine HCG Combo Kit (K852437) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 32 days after the submission was received.

What is the product code of K852437?

The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.