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 Aug 02, 2013
SOFIA(R) HCG FIA
K131166
Quidel Corp.
Chemistry · 100d
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 Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946
ACON Laboratories, Inc.
Chemistry · 28d
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 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
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801
Quidel Corp.
Chemistry · 66d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438
Sa Scientific, Inc.
Chemistry · 25d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522
Sa Scientific, Inc.
Toxicology · 159d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593
Sa Scientific, Inc.
Chemistry · 36d
Cleared Dec 02, 1999
CLEARVIEW EASY HCG PREGNANCY TEST
K993703
Unipath , Ltd.
Chemistry · 30d
Cleared Dec 01, 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Dec 01, 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317
ACON Laboratories, Inc.
Chemistry · 58d
Cleared Oct 08, 1999
ACON COMBO PREGNANCY
K993065
ACON Laboratories, Inc.
Chemistry · 25d
Cleared May 10, 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684
Sa Scientific, Inc.
Chemistry · 68d

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.