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
97–120 of 375
Cleared Apr 25, 1996
BIONIKE A/Q PREGNANCY TEST
K960992
Bionike Laboratories, Inc.
Chemistry · 44d
Cleared Mar 19, 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353
Tcpi, Inc.
Chemistry · 119d
Cleared Feb 29, 1996
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
K955266
Boehringer Mannheim Italia Spa
Chemistry · 106d
Cleared Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732
Bio-Rad Laboratories, Inc.
Chemistry · 49d
Cleared Oct 16, 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273
Quidel Corp.
Chemistry · 33d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029
Abbott Laboratories
Chemistry · 38d
Cleared Jun 20, 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319
Medix Biotech, Inc.
Chemistry · 33d
Cleared Feb 08, 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951
Syntron Bioresearch, Inc.
Chemistry · 64d
Cleared Jan 27, 1995
RAPIDVUE(TM) HCG
K945969
Quidel Corp.
Chemistry · 51d
Cleared Dec 07, 1994
VISUALINE II HCG
K943239
Sun Biomedical Laboratories, Inc.
Chemistry · 154d
Cleared Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426
Princeton BioMeditech Corp.
Chemistry · 43d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673
Abbott Laboratories
Chemistry · 207d
Cleared Apr 15, 1994
ONE STEP PREGNANCY TEST
K936031
Teco Diagnostics
Chemistry · 119d
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 Sep 28, 1993
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758
Medix Biotech, Inc.
Chemistry · 117d
Cleared Jul 08, 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279
Pb Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Jun 29, 1993
QUICKVUE ONE-STEP HCG COMBO
K932042
Quidel Corp.
Chemistry · 63d
Cleared Jun 15, 1993
PRO-STEP PT HCG
K925303
Disease Detection International, Inc.
Chemistry · 237d
Cleared Jun 09, 1993
SAS PREGNANCY STRIP
K931302
Sa Scientific, Inc.
Chemistry · 86d
Cleared May 11, 1993
CLEARVIEW HCG
K924673
Unipath , Ltd.
Chemistry · 237d
Cleared Mar 19, 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277
Ciba Corning Diagnostics Corp.
Chemistry · 150d
Cleared Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342
Syva Co.
Chemistry · 62d
Cleared Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
K926198
Bio-Rad Laboratories, Inc.
Chemistry · 61d