Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
2569–2592 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Nov 04, 1987
JOHNSON GRASS ALLERGEN DISC
K874150 · DHB
Incstar Corp.
Immunology · 22d
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