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

System, Test, Human Chorionic Gonadotropin

Regulation 862.1155

0510(k)s in 12 months (72 all time)
0recalls in 12 months (14 all time)
11recalls that name a 510(k)
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Top companies in DHA

Company510(k)sRecalls
Abbott Laboratories51
Dade Behring, Inc.32
Siemens Healthcare Diagnostics, Inc.23
Germaine Laboratories, Inc.40
Diagnostic Products Corp.30
Nichols Institute Diagnostics12
Ortho Clinical Diagnostics21
Roche Diagnostics30
Azog, Inc.20
Baxter Healthcare Corp20
Decided510(k)Device and applicantCode
May 8, 2024K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Ortho Clinical Diagnostics, GB
DHA
Dec 11, 2023K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Shenzhen Yhlo Biotech Co., Ltd., CN
DHA
Jun 5, 2023K230937Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Abbott Laboratories
DHA
May 19, 2023K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Abbott Laboratories
DHA
Dec 27, 2022K221990Access Total ßhCG (5th IS)
Beckman Coulter, Inc.
DHA
Dec 13, 2021K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
Diazyme Laboratories, Inc.
DHA
Aug 18, 2021K203227Elecsys HCG STAT
Roche Diagnostics
DHA
Jul 13, 2021K200210ADVIA Centaur® Total hCG assay
Siemens Healthcare Diagnostics, Inc.
DHA
Jan 17, 2020K192547MAGLUMI 2000 HCG/ß-HCG
Shenzhen New Industries Biomedical Engineering Co., Ltd., CN
DHA
Oct 30, 2019K192790Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics, Inc.
DHA
Oct 23, 2017K170317Alinity i Total ß-hCG Reagent Kit, Alinity i System
Abbott Laboratories
DHA
Aug 18, 2017K163418Diazyme DZ-Lite Total beta-hCG Test System
Diazyme Laboratories
DHA
Apr 16, 2015K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Abbott Point of Care, Inc.
DHA
Oct 1, 2013K130020ACCESS TOTAL BHCG (5TH IS)
Beckman Coulter, Inc.
DHA
Sep 6, 2013K131037LIAISON XL HCG
DiaSorin, Inc.
DHA
Apr 21, 2009K072500ONE STEP HCG URINE/SERUM TEST
Guangzhou Wondfo Biotech Co., Ltd.
DHA
Sep 3, 2008K080094OLYMPUS TOTAL BHCG TEST SYSTEN
Olympus Life Science Research Europa GmbH (Europa)
DHA
Apr 9, 2007K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
Ortho-Clinical Diagnostics
DHA
Feb 23, 2007K063754DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
Dade Behring, Inc.
DHA
Apr 6, 2006K060548STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
Dade Behring, Inc.
DHA
Dec 17, 2004K042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
Nichols Institute Diagnostics
DHA
Dec 12, 2003K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
Diagnostic Products Corp.
DHA
Jun 13, 2003K031052CARESTART HCG ONE-STEP PREGNANCY TEST
Access Bio Incorporate
DHA
Nov 1, 2002K022681AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
Azog, Inc.
DHA
Nov 1, 2002K022680AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
Azog, Inc.
DHA
Jan 22, 2002K013857AIMSTEP PREGNANCY
Germaine Laboratories, Inc.
DHA
Dec 27, 2001K013678VICTORCH MEDITEK'S HCG TEST CARD
Victorch Meditek, Inc.
DHA
Jan 25, 2001K003696STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
Dade Behring, Inc.
DHA
Dec 14, 2000K003178ELECSYS HCG AND BETA TEST SYSTEM
Roche Diagnostics Corp.
DHA
Aug 22, 2000K002148ELECSYS HCG TEST SYSTEM
Roche Diagnostics Corp.
DHA
Jun 16, 2000K000844ABSOLUTE HCG PREGNANCY TEST
Mizuho USA, Inc.
DHA
Jan 28, 2000K994085IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
Diagnostic Products Corp.
DHA
Sep 17, 1999K991532DRX QT. HCG
Metrika, Inc.
DHA
May 28, 1999K991515INSURE PREGNANCY TEST
Inbios Intl., Inc.
DHA
Feb 26, 1999K990222IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
Diagnostic Products Corp.
DHA
Dec 1, 1998K983424ABBOTT ARCHEITECT TOTAL B-HCG
Abbott Laboratories
DHA
Jan 2, 1998K974512AIMSTICK PBD COMBO PREGNANCY
Germaine Laboratories, Inc.
DHA
Jan 2, 1998K974368AIMSTICK PBD PREGNANCY
Germaine Laboratories, Inc.
DHA
Dec 24, 1997K974425BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
Princeton BioMeditech Corp.
DHA
Dec 19, 1997K973825MIDSTREAM HOME REGNANCY TEST
Germaine Laboratories, Inc.
DHA
Apr 14, 1997K970894VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
Johnson & Johnson Clinical Diagnostics, Inc.
DHA
Mar 10, 1997K970387HUMAN CHORIONIC GONADOTROPIN METHOD
Dade Chemistry Systems, Inc.
DHA
Aug 21, 1996K961792BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
Biocircuits Corp.
DHA
Jun 12, 1996K961487ELECSYS HCG ASSAY
Boehringer Mannheim Corp.
DHA
Jun 3, 1996K961351HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
Bayer Corp.
DHA
May 2, 1996K955707ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
Excel Scientific, Inc.
DHA
Jul 17, 1995K952283AMERLITE HCG-60 ASSAY
Johnson & Johnson Clinical Diagnostics, Inc.
DHA
Mar 20, 1995K945331AURAFLEX HCG
Organon Teknika Corp.
DHA
Mar 1, 1995K950307BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
Princeton BioMeditech Corp.
DHA
Aug 18, 1994K941983SEALITE SCIENCES INC.
Sealite Sciences, Inc.
DHA

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