JHI · Class II · 21 CFR 862.1155

FDA Product Code JHI: Visual, Pregnancy Hcg, Prescription Use

Leading manufacturers include Quidel Corp., Abbott Laboratories and Hybritech, Inc..

375
Total
375
Cleared
70d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Visual, Pregnancy Hcg, Prescription Use Devices (Product Code JHI)

375 devices
1–24 of 375
Cleared Aug 02, 2024
Innovita HCG Pregnancy Rapid Combo Test
K241919
Innovita (Tangshan) Biological Technology Co., Ltd.
Chemistry · 32d
Cleared Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
K203272
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 451d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Dec 22, 2017
TrueDX 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)
K172257
True Diagnostics, Inc.
Chemistry · 149d
Cleared Feb 24, 2016
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768
Assure Tech. Co., Ltd.
Chemistry · 153d
Cleared Apr 08, 2014
WUNDER PREGNANCY TEST
K130456
James Nguyen
Chemistry · 410d
Cleared Jan 09, 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834
Polymed Therapeutics, Inc.
Chemistry · 121d
Cleared Aug 02, 2013
SOFIA(R) HCG FIA
K131166
Quidel Corp.
Chemistry · 100d
Cleared May 30, 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
K123844
Chemtron Biotech, Inc.
Chemistry · 168d
Cleared Jul 17, 2012
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101
Polymed Therapeutics, Inc.
Chemistry · 361d
Cleared Apr 23, 2012
HOME PREGNANCY TEST
K112315
Newscen Coast Bio-Pharmaceutical Co., Ltd.
Chemistry · 256d
Cleared Aug 25, 2010
RAPIDVUE HCG TEST
K102175
Quidel Corporation
Chemistry · 23d
Cleared Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
K050955
Princeton BioMeditech Corp.
Chemistry · 283d
Cleared May 16, 2005
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
K050741
Ind Diagnostic, Inc.
Chemistry · 56d
Cleared Apr 12, 2005
OSOM HCG COMBO TEST
K043385
Genzyme Diagnostics
Chemistry · 124d
Cleared Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946
ACON Laboratories, Inc.
Chemistry · 28d
Cleared Aug 11, 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728
Immunostics Inc.,
Chemistry · 47d
Cleared Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
K032563
Bayer Healthcare, LLC
Chemistry · 125d
Cleared Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944
Bayer Corp.
Chemistry · 77d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544
Genzyme Corp.
Chemistry · 86d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683
Sa Scientific, Inc.
Chemistry · 126d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378
Stanbio Laboratory
Chemistry · 136d
Cleared May 23, 2002
STATUS HCG SERUM/URINE
K020439
Princeton BioMeditech Corp.
Chemistry · 101d

About Product Code JHI - Regulatory Context

510(k) Submission Activity

375 total 510(k) submissions under product code JHI since 1976, with 375 receiving FDA clearance (average review time: 70 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.