Evatest Strip

FDA 510(k) K936013 · Boehringer Mannheim Italia Spa

Substantially Equivalent

510(k) numberK936013

Submission

Device name
Evatest Strip
Applicant
Boehringer Mannheim Italia Spa
I-20126 Milano, Italy, IT
Received
December 16, 1993
Decision date
February 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1155
Specialty
Clinical Chemistry

Other 510(k)s with product code LCX

510(k)DeviceApplicantDecision
K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.09/09/2025SE
K251053Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.07/15/2025SE
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional Assure Tech., LLC02/13/2025SE
K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional Nanjing Synthgene Medical Technology Co., Ltd.01/31/2025SE
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional Assure Tech., LLC01/15/2025SE
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional Andon Health Co, Ltd.12/20/2024SE
K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional Anhui Deepblue Medical Technology Co., Ltd.10/11/2024SE
K241978Shinetell Digital Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.08/13/2024SE
K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.06/21/2024SE
K232715Distinct® Digital Pregnancy TestLCX · Traditional ACON Laboratories, Inc.05/31/2024SE

More from ACON Laboratories, Inc.

510(k)DeviceDecision
K955266Accustat HCG Serum Diluent Reagent or Event Serum DiluentJHI · Traditional 02/29/1996SE
K935502Event Test Strip HCGJHI · Traditional 01/27/1994SE

Questions and answers

When was Evatest Strip cleared by the FDA?

Evatest Strip (K936013) received a 510(k) decision of Substantially Equivalent on February 25, 1994, 71 days after the submission was received.

What is the product code of K936013?

The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.