JHJ · Class II · 21 CFR 862.1155

FDA Product Code JHJ: Agglutination Method, Human Chorionic Gonadotropin

Leading manufacturers include Organon, Inc., Armkel, LLC and Stanbio Laboratory.

96
Total
96
Cleared
70d
Avg days
1977
Since

FDA 510(k) Cleared Agglutination Method, Human Chorionic Gonadotropin Devices (Product Code JHJ)

96 devices
1–24 of 96
Cleared Jun 28, 1996
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968
Tech-Co, Inc.
Chemistry · 1523d
Cleared Feb 24, 1994
SAS(TM) DIRECT MONOCLONAL HCG
K935863
Sa Scientific, Inc.
Chemistry · 83d
Cleared Mar 29, 1993
SAS(TM) MONOCLONAL HCG-SLIDE
K930609
Sa Scientific, Inc.
Chemistry · 52d
Cleared Mar 24, 1992
DIRECT PREGNANCY TEST
K920716
Tech-Co, Inc.
Chemistry · 35d
Cleared Apr 01, 1991
CLEARVIEW HCG
K910946
Unipath , Ltd.
Chemistry · 26d
Cleared May 27, 1988
PREGNOSPIA II
K881435
Organon Teknika Corp.
Chemistry · 52d
Cleared Mar 15, 1988
HCG-NOSTICK
K880328
Organon Teknika Corp.
Chemistry · 49d
Cleared Sep 29, 1986
PREGNASLIDE
K863198
Armkel, LLC
Chemistry · 41d
Cleared Jul 29, 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703
Leeco Diagnostics, Inc.
Chemistry · 85d
Cleared Jul 11, 1986
DELFIA (TM) HCG KIT
K862044
Lkb Instruments, Inc.
Chemistry · 44d
Cleared May 02, 1986
DIRECTACLONE CG SLIDE PREGNANCY TEST
K860945
Pacific Biotech, Inc.
Chemistry · 51d
Cleared Feb 13, 1986
TERUMO SENSIBEAD EIG HCG KIT
K854670
Terumo Medical Corp.
Chemistry · 84d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Feb 12, 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914
Abbott Laboratories
Chemistry · 56d
Cleared Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544
Stanbio Laboratory
Chemistry · 81d
Cleared Aug 24, 1984
DUOCLON COLOR-CEPT
K842314
Organon, Inc.
Chemistry · 73d
Cleared Apr 04, 1984
B-NEOCEPT 30
K840650
Organon, Inc.
Chemistry · 49d
Cleared Feb 04, 1984
BHCG-CHECK
K834346
Diagnostic Technology, Inc.
Immunology · 54d
Cleared Feb 03, 1984
FERTITUBE PREGNANCY TEST #1120
K832867
Stanbio Laboratory
Chemistry · 163d
Cleared Jan 18, 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
K833137
Ortho Diagnostic Systems, Inc.
Chemistry · 126d
Cleared Nov 25, 1983
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K833156
Quidel Corp.
Chemistry · 70d
Cleared Oct 28, 1983
B-SLIDE PREGNATE PREGNANCY TEST KIT
K832879
Fisher Scientific Co., LLC
Chemistry · 63d
Cleared Oct 04, 1983
QUICK-TELL INDIRECT PREGNANCY TEST
K832640
Stanbio Laboratory
Chemistry · 61d
Cleared Sep 20, 1983
EARLY IN HOME PREGNANCY TEST
K832599
Warner-Lambert Co.
Chemistry · 49d

About Product Code JHJ - Regulatory Context