FDA.reportPublic FDA data

510(k) K262299

Device
Instant-View® hCG Combo II Cassette Test
Applicant
Alfa Scientific Designs, Inc.
510(k) number
K262299
Product code
JHI
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-22
Date received
2026-07-07
Regulation
862.1155
Classification name
Visual, Pregnancy Hcg, Prescription Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Michael Chien
Address
13200 Gregg St. Powat CA US 92064 92064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JHI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.2024-08-02
K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.2022-01-31
K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.2018-03-29
K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.2017-12-22
K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.2016-02-24
K130456WUNDER PREGNANCY TESTJames Nguyen2014-04-08
K132834FASTEP S10 HCG SERUM/URINE COMBO TESTPolymed Therapeutics, Inc.2014-01-09
K131166SOFIA(R) HCG FIAQuidel Corp.2013-08-02
K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTChemtron Biotech, Inc.2013-05-30
K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSPolymed Therapeutics, Inc.2012-07-17
K112315HOME PREGNANCY TESTNewscen Coast Bio-Pharmaceutical Co., Ltd.2012-04-23
K102175RAPIDVUE HCG TESTQuidel Corporation2010-08-25
K072264FASTPACK HCG IMMUNOASSAYQualigen, Inc.2007-12-06
K070921BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCGApplied Dna Technologies, Inc.2007-06-29
K071030BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGCApplied Dna Technologies, Inc.2007-06-29