LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Quidel Corp., Meridian Bioscience, Inc. and Meridian Diagnostics, Inc..

91
Total
91
Cleared
165d
Avg days
1988
Since
91 devices
49–72 of 91
Cleared Mar 10, 1998
PYLORI DETECT IGG
K973508
Micro Detect, Inc.
Microbiology · 175d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523
Boehringer Mannheim Corp.
Microbiology · 167d
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146
Consolidated Technologies, Inc.
Microbiology · 29d
Cleared Jun 27, 1997
PYLORISET EIA-G (68926)
K971537
Orion Diagnostica, Div. Orion Corp.
Microbiology · 60d
Cleared Mar 03, 1997
KENLOR H. PYLORI CONTROL SERUM
K964014
Kenlor Industries, Inc.
Microbiology · 147d
Cleared Feb 20, 1997
ACCUMETER H. PYLORI TEST
K965099
Chemtrak, Inc.
Microbiology · 62d
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675
Pyramid Biological Corp.
Microbiology · 67d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared Sep 17, 1996
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220
Meretek Diagnostics, Inc.
Microbiology · 495d
Cleared Aug 30, 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873
Elias U.S.A., Inc.
Microbiology · 379d
Cleared Jul 30, 1996
PYLORI IGG ELISA TEST SYSTEM
K961221
Armkel, LLC
Microbiology · 132d
Cleared Jun 27, 1996
ACCUMETER H. PYLORI TEST
K960478
Chemtrak, Inc.
Microbiology · 146d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared May 21, 1996
HELISAL RAPID BLOOD TEST
K953686
Cortecs, Ltd.
Microbiology · 295d
Cleared Feb 09, 1996
HM-CAP EIA TEST (MODIFICATION)
K955085
Schiff & Co.
Microbiology · 106d
Cleared Feb 06, 1996
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517
Quidel Corp.
Microbiology · 251d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926
E-Z-Em, Inc.
Microbiology · 96d
Cleared Dec 18, 1995
SERIM PYLORITEK TEST KIT
K953632
Serim Research Corp.
Microbiology · 151d
Cleared Jul 18, 1995
HM-CAP EIA KIT
K944159
Schiff & Co.
Microbiology · 326d
Cleared May 11, 1995
PS II
K943513
Washington Biotechnology
Microbiology · 295d
Cleared Apr 20, 1995
HP-FAST
K944903
Gi Supply
Microbiology · 198d
Cleared Apr 05, 1995
PYLORISET DRY
K942974
Orion Diagnostica, Div. Orion Corp.
Microbiology · 289d
Cleared Mar 03, 1995
PREMIER(TM) H. PYLORY
K945558
Meridian Diagnostics, Inc.
Microbiology · 109d
Cleared Dec 08, 1994
IMMUNOCARD H. PYLORI
K941560
Meridian Diagnostics, Inc.
Microbiology · 251d