JHI · Class II · 21 CFR 862.1155

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

Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Eastman Kodak Company.

375
Total
375
Cleared
70d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 32d recently vs 71d historically

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 20, 2002
ACCESS TOTAL BHCG
K023480
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Mar 18, 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116
Abbott Laboratories
Chemistry · 62d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029
Abbott Laboratories
Chemistry · 38d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673
Abbott Laboratories
Chemistry · 207d
Cleared Apr 08, 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 08, 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287
Eastman Kodak Company
Chemistry · 106d
Cleared Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342
Syva Co.
Chemistry · 62d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 67d
Cleared Mar 23, 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505
Eastman Kodak Company
Chemistry · 47d
Cleared Jan 27, 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701
Eastman Kodak Company
Chemistry · 49d
Cleared Jul 01, 1991
IMX HCG
K912534
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535
Abbott Laboratories
Chemistry · 24d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219
Abbott Laboratories
Chemistry · 64d
Cleared Aug 09, 1990
AFFINITY HCG TEST SYSTEM
K902720
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 50d
Cleared Jun 28, 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136
Eastman Kodak Company
Chemistry · 49d
Cleared Apr 18, 1990
IMX HCG (LIST #03A63)
K900327
Abbott Laboratories
Chemistry · 85d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 23d
Cleared Feb 08, 1990
ENZYMUN TEST R HCG
K896901
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809
Diagnostic Products Corp.
Chemistry · 90d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941
Diagnostic Products Corp.
Chemistry · 83d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JHI Product Code

Recent submissions under JHI have taken an average of 32 days to reach a decision - down from 71 days historically, suggesting improved FDA processing for this classification.

JHI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →