FDA Product Code LYR: Helicobacter Pylori

Cleared May 18, 1994

FLEXSURE HP

K934863

Smithkline Diagnostics, Inc.

Microbiology · 218d

Cleared Aug 10, 1993

UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG

K924689

United Biotech, Inc.

Microbiology · 327d

Cleared Mar 23, 1993

PYLORISCREEN

K925190

New Horizons Diagnostics Co.

Microbiology · 160d

Cleared Sep 11, 1992

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED

K923445

Hycor Biomedical, Inc.

Microbiology · 65d

Cleared Jul 14, 1992

AMRAD HEL-PTEST

K920827

Amrad

Microbiology · 141d

Cleared Mar 04, 1992

GAP IGG H.PYLORI MODIFIED

K915185

Biomerica, Inc.

Microbiology · 107d

Cleared Feb 21, 1992

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

K915851

Quidel Corp.

Microbiology · 56d

Cleared Oct 21, 1991

PYLORISET

K904655

Orion Diagnostica, Inc.

Microbiology · 374d

Cleared Oct 11, 1991

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST

K912255

Hycor Biomedical, Inc.

Microbiology · 142d

Cleared Oct 04, 1991

PYLORITRAK

K912215

Bainbridge Laboratories, Inc.

Microbiology · 137d

Cleared Sep 16, 1991

QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST

K912442

Quidel Corp.

Microbiology · 105d

Cleared Aug 22, 1991

GAP-IGG

K900343

Biomerica, Inc.

Microbiology · 576d

Cleared Jun 10, 1991

EIA FOR DETECTION OF ANTIBODIES H. PYLORI

K905409

E-Z-Em, Inc.

Microbiology · 189d

Cleared May 07, 1991

PYLORI STAT TEST KIT

K904738

Whittaker Bioproducts, Inc.

Microbiology · 201d

Cleared May 07, 1991

QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

K905049

Quidel Corp.

Microbiology · 180d

Cleared May 07, 1991

PYLORI-G FIAX TEST KIT

K905468

Whittaker Bioproducts, Inc.

Microbiology · 152d

Cleared Apr 17, 1991

QUIDEL HELICOBACTER PYLORI TEST

K903099

Quidel Corp.

Microbiology · 278d

Cleared May 04, 1989

SELECTIVE RAPID UREA

K883641

Remel Co.

Microbiology · 252d

Cleared Oct 06, 1988

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST

K882199

Auspharm Intl. , Ltd.

Microbiology · 134d