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
96 devices
25–48 of 96
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
Cleared Sep 12, 1983
FERTITELL DIRECT PREGNANCY TEST #1100
K832557
Stanbio Laboratory
Chemistry · 42d
Cleared Aug 16, 1983
GAMMA SLIDE TEST FOR PREGNANCY
K832473
Gamma Biologicals, Inc.
Chemistry · 21d
Cleared Aug 11, 1983
UCG-BETA SLIDE MONOCLONAL
K831775
Armkel, LLC
Chemistry · 70d
Cleared Jun 30, 1983
E.P.T. PLUS TM
K831535
Warner-Lambert Co.
Chemistry · 48d
Cleared Jun 22, 1983
EVENT-TEST SLIDE
K831383
Icl Scientific
Chemistry · 55d
Cleared Jun 22, 1983
HCG-CHECK
K831466
Diagnostic Technology, Inc.
Immunology · 47d
Cleared Jun 22, 1983
B HCG-CHECK
K831468
Diagnostic Technology, Inc.
Immunology · 47d
Cleared Jun 08, 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339
Organon, Inc.
Immunology · 44d
Cleared Jan 07, 1983
BETA FFIRM TEST
K823682
Organon, Inc.
Chemistry · 31d
Cleared Jun 02, 1982
PREG/TEX PREGNANCY TEST
K821387
Texas Immunology, Inc.
Immunology · 23d
Cleared Nov 06, 1981
ACCURATE BETA
K812967
Organon, Inc.
Chemistry · 15d
Cleared Nov 02, 1981
ANSWER (R)
K812924
Armkel, LLC
Chemistry · 14d
Cleared Sep 01, 1981
B-NEOCEPT
K812334
Organon, Inc.
Chemistry · 14d
Cleared Aug 31, 1981
ACCURATE I
K812261
Organon, Inc.
Chemistry · 19d
Cleared Aug 03, 1981
OREIA II, B-HCG
K811940
Organon, Inc.
Chemistry · 28d
Cleared Jul 27, 1981
NEOCEPT
K811941
Organon, Inc.
Chemistry · 21d
Cleared Dec 19, 1980
RAPI-DOT
K802974
Organon, Inc.
Chemistry · 28d
Cleared Nov 24, 1980
ANSWER AT-HOME PREGNANCY TEST KIT
K802660
Armkel, LLC
Chemistry · 31d
Cleared Oct 31, 1980
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
K802450
Syn-Kit, Inc.
Chemistry · 23d
Cleared Oct 23, 1980
UCG-BETA STAT
K802421
Armkel, LLC
Chemistry · 17d