ClearanceBrief
Panels › Clinical Chemistry › Product code JHI · Class 2

Visual, Pregnancy Hcg, Prescription Use

Regulation 862.1155

1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
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Top companies in JHI

Company510(k)sRecalls
Quidel Corp.201
Abbott Laboratories150
Hybritech, Inc.140
Pacific Biotech, Inc.130
Leeco Diagnostics, Inc.100
Bd Becton Dickinson Vacutainer Systems Preanalytic90
Medix Biotech, Inc.90
Sa Scientific, Inc.90
Mainline Technology, Inc.17
Hoffmann-La Roche, Inc.70
Decided510(k)Device and applicantCode
Apr 5, 2001K010593SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
Sa Scientific, Inc.
JHI
Feb 21, 2001K003856EZ-HCG URINE(PREGNANCY TEST)
Biomerica, Inc.
JHI
Jun 22, 2000K001215DBEST HCG 2 IU/ML TEST KIT
Ameritek, Inc.
JHI
Feb 3, 2000K994227ADVANTAGE HCG TEST (URINE/SERUM)
Advantage Diagnostics Corp.
JHI
Dec 2, 1999K993703CLEARVIEW EASY HCG PREGNANCY TEST
Unipath , Ltd., GB
JHI
Dec 1, 1999K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
ACON Laboratories, Inc.
JHI
Dec 1, 1999K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)
ACON Laboratories, Inc.
JHI
Nov 18, 1999K992915ONE-STEP DOUBLE-CHEK PREGNANCY TEST
Biomedical Products Corp.
JHI
Oct 18, 1999K992695INSURE PRO TEST
Inbios Intl., Inc.
JHI
Oct 8, 1999K993065ACON COMBO PREGNANCY
ACON Laboratories, Inc.
JHI
Aug 26, 1999K992397ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
Cenogenics Corp.
JHI
Jul 22, 1999K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
Biocheck, Inc.
JHI
May 10, 1999K990741SAS ONE-STEP PREGNANCY
Sa Scientific, Inc.
JHI
May 10, 1999K990684MODIFICATION OF SAS SERUM/URINE HCG
Sa Scientific, Inc.
JHI
Apr 28, 1999K991095QUICKCARD HCG COMBO TEST, MODEL #9014
Phamatech
JHI
Apr 27, 1999K991067MODIFICATION OF: DAVIDSTRIP HCG
Simex Medical, Inc.
JHI
Mar 9, 1999K990578OSOM CARD II HCG-URINE TEST, MODEL 102
Wyntek Diagnostics, Inc.
JHI
Feb 16, 1999K984080INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
Alfa Scientific Designs, Inc.
JHI
Feb 16, 1999K984079INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
Alfa Scientific Designs, Inc.
JHI
Feb 16, 1999K984077INSTANT-VIEW PREGNANCY COMBO TEST
Alfa Scientific Designs, Inc.
JHI
Feb 16, 1999K984076INSTANT-VIEW PREGNANCY URINE TEST
Alfa Scientific Designs, Inc.
JHI
Jul 22, 1998K981444BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
Princeton BioMeditech Corp.
JHI
Jun 25, 1998K981838ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
Unotech Diagnostics, Inc.
JHI
Jun 25, 1998K981443BIOSIGN HCG I - ONE STEP PREGNANCY TEST
Princeton BioMeditech Corp.
JHI
Jun 5, 1998K981770RAPIDHCG PREGNANCY TEST
Rapid Diagnostics, Inc.
JHI
May 28, 1998K981512ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
Skd, Inc. A Beckman Coulter Co.
JHI
Apr 16, 1998K981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
Germaine Laboratories, Inc.
JHI
Apr 16, 1998K980736ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
Acon Laboratories Co.
JHI
Apr 9, 1998K974060MINISTRIP/ SERUM AND URINE COMBO HCG TEST
International Newtech Development, Inc., CA
JHI
Apr 2, 1998K980896QUICKCARD PRO HCG TEST, MODEL 9008
Phamatech
JHI
Mar 18, 1998K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
Beckman Instruments, Inc.
JHI
Mar 13, 1998K974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
International Newtech Development, Inc., CA
JHI
Mar 6, 1998K980531AIMSTEP PREGNANCY
Germaine Laboratories, Inc.
JHI
Feb 12, 1998K980205SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
San Diego Biotech
JHI
Jan 26, 1998K974615QUICKSTICK PRO HCG TEST
Phamatech
JHI
Jan 22, 1998K974851SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
San Diego Biotech
JHI
Dec 24, 1997K974159OSOM HCG-URINE TEST MODEL 101
Wyntek Diagnostics, Inc.
JHI
Dec 19, 1997K974052QUICKVUE SEMI-Q HCG-COMBO
Quidel Corp.
JHI
Dec 17, 1997K973957DBEST ONE-STEP HCG SERUM/URINE TEST
Ameritek, Inc.
JHI
Dec 1, 1997K973841QUICKVUE ONE-STEP HCG-COMBO
Quidel Corp.
JHI
Nov 26, 1997K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
Quidel Corp.
JHI
Nov 4, 1997K973879OSOM CARD HCG-URINE TEST
Wyntek Diagnostics, Inc.
JHI
Aug 29, 1997K972748CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
Quidel Corp.
JHI
Aug 29, 1997K972742QUICKVUE ONE-STEP HCG-URINE
Quidel Corp.
JHI
Jun 11, 1997K971886ACCUTEST HCG-URINE
Unotech Diagnostics, Inc.
JHI
Apr 25, 1997K971122ACCULINE PREGNANCY TEST
Genix Biotek, Inc.
JHI
Apr 4, 1997K971209CLINITEK HCG TEST STRIPS
Bayer Corp.
JHI
Mar 6, 1997K970424EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
Excel Scientific, Inc.
JHI
Feb 20, 1997K965116ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
Abbott Laboratories
JHI
Feb 20, 1997K964633ACCUPACK PREGNANCY TEST
Genix Biotek, Inc.
JHI

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