Medical Device Manufacturer · US , Lake Success , NY

Olympus America, Inc. - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1994
149
Total
149
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus America, Inc. Immunology
19 devices
1-19 of 19
Cleared Mar 18, 2009
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K081615 · DHX
Immunology · 282d
Cleared Feb 11, 2008
OLYMPUS IGM REAGENT
K073487 · CFN
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGA REAGENT
K073489 · CFN
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGG REAGENT
K073490 · CFN
Immunology · 61d
Cleared Jun 06, 2006
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S):...
K060201 · DHR
Immunology · 131d
Cleared Feb 06, 2003
OLYMPUS FERRITIN REAGENT
K030124 · DBF
Immunology · 23d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · DCN
Immunology · 36d
Cleared May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · JZG
Immunology · 36d
Cleared Feb 06, 1997
OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
K963139 · DDD
Immunology · 178d
Cleared Dec 02, 1996
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · DBF
Immunology · 110d
Cleared Oct 18, 1996
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · CZW
Immunology · 119d
Cleared Oct 18, 1996
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · DBI
Immunology · 109d
Cleared Feb 14, 1996
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · DCN
Immunology · 138d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · DHR
Immunology · 28d
Cleared Jul 05, 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425 · JHN
Immunology · 42d
Cleared Jun 05, 1995
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466 · JHN
Immunology · 10d
Cleared Apr 17, 1995
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
K951013 · CFQ
Immunology · 42d
Cleared Apr 17, 1995
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · CFQ
Immunology · 41d
Cleared Mar 27, 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · CFQ
Immunology · 27d
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