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Helicobacter Pylori

Regulation 866.3110

0510(k)s in 12 months (91 all time)
2recalls in 12 months (11 all time)
5recalls that name a 510(k)
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Top companies in LYR

Company510(k)sRecalls
Meridian Bioscience, Inc.61
Quidel Corp.60
BIOMERIEUX23
Meridian Diagnostics, Inc.50
Biomerica, Inc.30
Calbiotech Inc02
Chemtrak, Inc.20
Diagnostic Products Corp.11
DiaSorin, Inc.20
E-Z-Em, Inc.20
Decided510(k)Device and applicantCode
Jul 8, 1997K972146QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
Consolidated Technologies, Inc.
LYR
Jun 27, 1997K971537PYLORISET EIA-G (68926)
Orion Diagnostica, Div. Orion Corp., FI
LYR
Mar 3, 1997K964014KENLOR H. PYLORI CONTROL SERUM
Kenlor Industries, Inc.
LYR
Feb 20, 1997K965099ACCUMETER H. PYLORI TEST
Chemtrak, Inc.
LYR
Jan 27, 1997K964675H.PYLORI CONTROLS
Pyramid Biological Corp.
LYR
Jan 21, 1997K961508IMMUNOCARD H. PYLORI
Meridian Diagnostics, Inc.
LYR
Sep 17, 1996K952220MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
Meretek Diagnostics, Inc.
LYR
Aug 30, 1996K953873VARELISA HELICOBACTER PYLORI ANTIBODIES
Elias U.S.A., Inc.
LYR
Jul 30, 1996K961221PYLORI IGG ELISA TEST SYSTEM
Armkel, LLC
LYR
Jun 27, 1996K960478ACCUMETER H. PYLORI TEST
Chemtrak, Inc.
LYR
Jun 7, 1996K960183FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
Smithkline Diagnostics, Inc.
LYR
May 21, 1996K953686HELISAL RAPID BLOOD TEST
Cortecs, Ltd.
LYR
Feb 9, 1996K955085HM-CAP EIA TEST (MODIFICATION)
Schiff & Co.
LYR
Feb 6, 1996K952517QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
Quidel Corp.
LYR
Jan 30, 1996K954926HM-CAP CONTROL PANEL
E-Z-Em, Inc.
LYR
Dec 18, 1995K953632SERIM PYLORITEK TEST KIT
Serim Research Corp.
LYR
Jul 18, 1995K944159HM-CAP EIA KIT
Schiff & Co.
LYR
May 11, 1995K943513PS II
Washington Biotechnology
LYR
Apr 20, 1995K944903HP-FAST
Gi Supply
LYR
Apr 5, 1995K942974PYLORISET DRY
Orion Diagnostica, Div. Orion Corp., FI
LYR
Mar 3, 1995K945558PREMIER(TM) H. PYLORY
Meridian Diagnostics, Inc.
LYR
Dec 8, 1994K941560IMMUNOCARD H. PYLORI
Meridian Diagnostics, Inc.
LYR
May 18, 1994K934863FLEXSURE HP
Smithkline Diagnostics, Inc.
LYR
Aug 10, 1993K924689UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
United Biotech, Inc.
LYR
Mar 23, 1993K925190PYLORISCREEN
New Horizons Diagnostics Co.
LYR
Sep 11, 1992K923445PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
Hycor Biomedical, Inc.
LYR
Jul 14, 1992K920827AMRAD HEL-PTEST
Amrad
LYR
Mar 4, 1992K915185GAP IGG H.PYLORI MODIFIED
Biomerica, Inc.
LYR
Feb 21, 1992K915851QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
Quidel Corp.
LYR
Oct 21, 1991K904655PYLORISET
Orion Diagnostica, Inc., FI
LYR
Oct 11, 1991K912255HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
Hycor Biomedical, Inc.
LYR
Oct 4, 1991K912215PYLORITRAK
Bainbridge Laboratories, Inc.
LYR
Sep 16, 1991K912442QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
Quidel Corp.
LYR
Aug 22, 1991K900343GAP-IGG
Biomerica, Inc.
LYR
Jun 10, 1991K905409EIA FOR DETECTION OF ANTIBODIES H. PYLORI
E-Z-Em, Inc.
LYR
May 7, 1991K905468PYLORI-G FIAX TEST KIT
Whittaker Bioproducts, Inc.
LYR
May 7, 1991K905049QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
Quidel Corp.
LYR
May 7, 1991K904738PYLORI STAT TEST KIT
Whittaker Bioproducts, Inc.
LYR
Apr 17, 1991K903099QUIDEL HELICOBACTER PYLORI TEST
Quidel Corp.
LYR
May 4, 1989K883641SELECTIVE RAPID UREA
Remel Co.
LYR
Oct 6, 1988K882199CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
Auspharm Intl. , Ltd.
LYR

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