Accustat HCG Serum Diluent Reagent or Event Serum Diluent

Q: What is the product code of K955266?

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

FDA 510(k) K955266 · Boehringer Mannheim Italia Spa

Substantially Equivalent

510(k) numberK955266

Submission

Device name: Accustat HCG Serum Diluent Reagent or Event Serum Diluent
Applicant: Boehringer Mannheim Italia Spa
Simi Valley, CA, US
Received: November 15, 1995
Decision date: February 29, 1996
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)	Device	Applicant	Decision
K241919	Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional	Innovita (Tangshan) Biological Technology Co.…	08/02/2024SE
K203272	Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional	Hangzhou AllTest Biotech Co., Ltd.	01/31/2022SE
K172322	Atellica IM Total hCG (ThCG)JHI · Traditional	Siemens Healthcare Diagnostics, Inc.	03/29/2018SE
K172257	TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional	True Diagnostics, Inc.	12/22/2017SE
K152768	Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional	Assure Tech. Co., Ltd.	02/24/2016SE
K130456	Wunder Pregnancy TestJHI · Traditional	James Nguyen	04/08/2014SE
K132834	Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional	Polymed Therapeutics, Inc.	01/09/2014SE
K131166	Sofia(R) HCG FiaJHI · Traditional	Quidel Corp.	08/02/2013SE
K123844	Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional	Chemtron Biotech, Inc.	05/30/2013SE
K112101	Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional	Polymed Therapeutics, Inc.	07/17/2012SE

More from Polymed Therapeutics, Inc.

510(k)	Device	Decision
K936013	Evatest StripLCX · Traditional	02/25/1994SE
K935502	Event Test Strip HCGJHI · Traditional	01/27/1994SE

Questions and answers

When was Accustat HCG Serum Diluent Reagent or Event Serum Diluent cleared by the FDA?

Accustat HCG Serum Diluent Reagent or Event Serum Diluent (K955266) received a 510(k) decision of Substantially Equivalent on February 29, 1996, 106 days after the submission was received.

What is the product code of K955266?

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