Innovita HCG Pregnancy Rapid Combo Test

FDA 510(k) K241919 · Innovita (Tangshan) Biological Technology Co., Ltd.

Substantially Equivalent

510(k) numberK241919

Submission

Device name
Innovita HCG Pregnancy Rapid Combo Test
Applicant
Innovita (Tangshan) Biological Technology Co., Ltd.
Qian'An, CN
Received
July 1, 2024
Decision date
August 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

510(k)DeviceApplicantDecision
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
K112315Home Pregnancy TestJHI · Traditional Newscen Coast Bio-Pharmaceutical Co., Ltd.04/23/2012SE

More from Newscen Coast Bio-Pharmaceutical Co., Ltd.

510(k)DeviceDecision
K250398Innovita Flu A/B Antigen Rapid TestPSZ · Traditional 07/03/2025SE
K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette…LCX · Traditional 11/22/2019SE

Questions and answers

When was Innovita HCG Pregnancy Rapid Combo Test cleared by the FDA?

Innovita HCG Pregnancy Rapid Combo Test (K241919) received a 510(k) decision of Substantially Equivalent on August 2, 2024, 32 days after the submission was received.

What is the product code of K241919?

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