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
49–72 of 96
Cleared Oct 23, 1980
UCG-BETA SLIDE
K802435
Armkel, LLC
Chemistry · 17d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jun 15, 1979
PREGNOSTICON PREGNANCY TEST KIT
K790734
Organon, Inc.
Chemistry · 60d
Cleared Apr 04, 1979
PREGNANCY, SENSIDEX TUBE TEST
K782063
Ortho Diagnostics, Inc.
Chemistry · 114d
Cleared Apr 04, 1979
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
K782166
Ortho Diagnostics, Inc.
Chemistry · 96d
Cleared Mar 21, 1979
SENSI-TEX
K790267
Hoffmann-La Roche, Inc.
Chemistry · 43d
Cleared Feb 01, 1979
PREGNANCY TEST KIT, DAISY 2 IN HOME
K790002
Boehringer Mannheim Corp.
Chemistry · 30d