FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
2569–2592 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 20, 1987
EUROGENETICS CRP ELISA
K872539 · DCN
Eurogenetics
Immunology · 113d
Cleared Oct 20, 1987
ANTINUCLEAR ANTIBODY TEST
K872839 · LJM
Cappel Diagnostics, Inc.
Immunology · 92d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K872946 · DHB
Pharmacia, Inc.
Immunology · 84d
Cleared Oct 20, 1987
PHARMACIA IGE EIA
K873077 · JHR
Pharmacia, Inc.
Immunology · 76d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K873112 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Oct 20, 1987
BERMUDA GRASS ALLERGEN DISC
K873770 · DHB
Incstar Corp.
Immunology · 34d
Cleared Oct 20, 1987
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
K873814 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 20, 1987
ALBUMIN IN SERUM
K873862 · DCF
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
HAPTOGLOBIN
K873866 · DAD
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · LKL
Unipath , Ltd.
Immunology · 57d
Cleared Oct 13, 1987
ALBUMIN IN URINE
K873861 · DCF
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
CRP
K873865 · DCK
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
TRANSFERRIN
K873867 · DDG
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS A
K873869 · CZP
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS G
K873870 · DEW
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS M
K873871 · DFT
Unipath , Ltd.
Immunology · 50d
Cleared Oct 08, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K873193 · DHB
Pharmacia, Inc.
Immunology · 56d
Cleared Oct 08, 1987
BAHIA ALLERGEN DISC
K873648 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 07, 1987
MODIFIED PHADEBAS RAST/PHADEZYM RAST
K872280 · DHB
Pharmacia, Inc.
Immunology · 113d
Cleared Oct 07, 1987
RED TOP ALLERGEN DISC
K873486 · DHB
Incstar Corp.
Immunology · 37d
Cleared Oct 07, 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 35d
Cleared Oct 07, 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · DHB
Incstar Corp.
Immunology · 23d