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Panels › Clinical Chemistry › Product code JHJ · Class 2

Agglutination Method, Human Chorionic Gonadotropin

Regulation 862.1155

0510(k)s in 12 months (96 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in JHJ

Company510(k)sRecalls
Organon, Inc.110
Armkel, LLC60
Stanbio Laboratory40
Cal-Tech Diagnostics, Inc.30
Diagnostic Technology, Inc.30
Immunostics Co., Inc.30
Intl. Diagnostic, Inc.30
Monoclonal Antibodies, Inc.30
PerkinElmer Life and Analytical Sciences, Wallac, OY03
Texas Immunology, Inc.30
Decided510(k)Device and applicantCode
Aug 11, 1983K831775UCG-BETA SLIDE MONOCLONAL
Armkel, LLC
JHJ
Jun 30, 1983K831535E.P.T. PLUS TM
Warner-Lambert Co.
JHJ
Jun 22, 1983K831468B HCG-CHECK
Diagnostic Technology, Inc.
JHJ
Jun 22, 1983K831466HCG-CHECK
Diagnostic Technology, Inc.
JHJ
Jun 22, 1983K831383EVENT-TEST SLIDE
Icl Scientific
JHJ
Jun 8, 1983K831339NEO-PREGNOSTICON DUOCLON TUBE TEST
Organon, Inc.
JHJ
Jun 2, 1983K831366TESTCORP PREG
Catheter Technology Corp.
JHJ
Jun 2, 1983K831361BETA-PREG
Catheter Technology Corp.
JHJ
Jun 2, 1983K831155B-CLONE HCG ASSAY
Monoclonal Antibodies, Inc.
JHJ
May 27, 1983K831180PREGNA-CERT, SLIDE PREGNANCY TEST
Diagnostic Specialties
JHJ
May 5, 1983K831125BTC URINE LCG ASSAY
Btc Diagnostics, Inc.
JHJ
Feb 9, 1983K830156HCG SCREENING TEST
Tago, Inc.
JHJ
Jan 7, 1983K823682BETA FFIRM TEST
Organon, Inc.
JHJ
Jul 16, 1982K821676PREG-PHILE B
Bio Diagnostic Systems, Inc.
JHJ
Jun 11, 1982K821552PREG-KNOW
Immuno Pathology Labs
JHJ
Jun 2, 1982K821387PREG/TEX PREGNANCY TEST
Texas Immunology, Inc.
JHJ
Dec 17, 1981K812789ACU-SLIDE TEST
C.F. Medical, Inc.
JHJ
Dec 17, 1981K812788A-1 TEST
C.F. Medical, Inc.
JHJ
Nov 6, 1981K812967ACCURATE BETA
Organon, Inc.
JHJ
Nov 2, 1981K812924ANSWER (R)
Armkel, LLC
JHJ
Sep 1, 1981K812334B-NEOCEPT
Organon, Inc.
JHJ
Aug 31, 1981K812261ACCURATE I
Organon, Inc.
JHJ
Aug 3, 1981K811940OREIA II, B-HCG
Organon, Inc.
JHJ
Jul 27, 1981K811941NEOCEPT
Organon, Inc.
JHJ
Mar 17, 1981K810581FACT* HOME PREGNANCY TEST
Ortho Pharmaceutical Corp.
JHJ
Dec 19, 1980K802974RAPI-DOT
Organon, Inc.
JHJ
Nov 24, 1980K802660ANSWER AT-HOME PREGNANCY TEST KIT
Armkel, LLC
JHJ
Oct 31, 1980K802450GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
Syn-Kit, Inc.
JHJ
Oct 23, 1980K802435UCG-BETA SLIDE
Armkel, LLC
JHJ
Oct 23, 1980K802421UCG-BETA STAT
Armkel, LLC
JHJ
Oct 10, 1980K802343PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO
Intl. Diagnostic, Inc.
JHJ
Oct 10, 1980K802334IN-HOME EARLY PREGNANCY TEST KIT
Health Diagnostics Corp.
JHJ
Jan 29, 1980K800055H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
Technam, Inc.
JHJ
Jan 16, 1980K792657SENSI-SLIDE
Hoffmann-La Roche, Inc.
JHJ
Oct 30, 1979K792027PREGTELL I
Central Biological Co.
JHJ
Oct 17, 1979K791706BE-SURE
Precision Products Corp.
JHJ
Oct 2, 1979K791609BE-SURE
Biologics Intl., Inc.
JHJ
Jul 30, 1979K791309UCG-LYPHOTEST
Wampole Laboratories
JHJ
Jul 30, 1979K790898PREG-TEX
Biologics Intl., Inc.
JHJ
Jun 15, 1979K790734PREGNOSTICON PREGNANCY TEST KIT
Organon, Inc.
JHJ
Apr 4, 1979K782166SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
Ortho Diagnostics, Inc.
JHJ
Apr 4, 1979K782063PREGNANCY, SENSIDEX TUBE TEST
Ortho Diagnostics, Inc.
JHJ
Mar 21, 1979K790267SENSI-TEX
Hoffmann-La Roche, Inc.
JHJ
Feb 1, 1979K790002PREGNANCY TEST KIT, DAISY 2 IN HOME
Boehringer Mannheim Corp.
JHJ
Jun 29, 1978K781049ACU-TEST IN-HOME PREGNANCY TEST
Williams, the J.B. Co., Inc.
JHJ
Sep 12, 1977K771514PREGNANCY TEST KIT
Generic Laboratory, Ltd.
JHJ

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