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
375 devices
49–72 of 375
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
K984080
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444
Princeton BioMeditech Corp.
Chemistry · 91d
Cleared Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443
Princeton BioMeditech Corp.
Chemistry · 64d
Cleared Jun 25, 1998
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
K981838
Unotech Diagnostics, Inc.
Chemistry · 30d
Cleared Jun 05, 1998
RAPIDHCG PREGNANCY TEST
K981770
Rapid Diagnostics, Inc.
Chemistry · 17d
Cleared May 28, 1998
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
K981512
Skd, Inc. A Beckman Coulter Co.
Chemistry · 30d
Cleared Apr 16, 1998
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
K980736
Acon Laboratories Co.
Chemistry · 50d
Cleared Apr 16, 1998
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
K981165
Germaine Laboratories, Inc.
Chemistry · 16d
Cleared Apr 09, 1998
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
K974060
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 02, 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896
Phamatech
Chemistry · 24d
Cleared Mar 18, 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Mar 13, 1998
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
K974009
International Newtech Development, Inc.
Chemistry · 143d
Cleared Mar 06, 1998
AIMSTEP PREGNANCY
K980531
Germaine Laboratories, Inc.
Chemistry · 23d
Cleared Feb 12, 1998
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
K980205
San Diego Biotech
Chemistry · 23d
Cleared Jan 26, 1998
QUICKSTICK PRO HCG TEST
K974615
Phamatech
Chemistry · 46d
Cleared Jan 22, 1998
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
K974851
San Diego Biotech
Chemistry · 24d
Cleared Dec 24, 1997
OSOM HCG-URINE TEST MODEL 101
K974159
Wyntek Diagnostics, Inc.
Chemistry · 71d
Cleared Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052
Quidel Corp.
Chemistry · 53d
Cleared Dec 17, 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957
Ameritek, Inc.
Chemistry · 62d
Cleared Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841
Quidel Corp.
Chemistry · 54d
Cleared Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
K973858
Quidel Corp.
Chemistry · 48d
Cleared Nov 04, 1997
OSOM CARD HCG-URINE TEST
K973879
Wyntek Diagnostics, Inc.
Chemistry · 55d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748
Quidel Corp.
Chemistry · 37d