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
793–816 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
K024221 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
K024222 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
K024224 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
K024225 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
K024227 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
K024229 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND...
K024230 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · LKJ
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231 · DHN
Bio-Rad
Immunology · 21d
Cleared Jan 10, 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · LKJ
Bio-Rad
Immunology · 18d
Cleared Jan 06, 2003
SERAQUEST ANTI-THYROGLOBULIN
K023592 · DDC
Quest Intl., Inc.
Immunology · 73d
Cleared Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K024196 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Dec 24, 2002
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · JIF
Bayer Diagnostics Corp.
Immunology · 36d
Cleared Dec 23, 2002
PAROS CRP
K022690 · DCN
Horiba, Ltd.
Immunology · 132d
Cleared Dec 23, 2002
AIA-PACK CA 19-9
K023239 · NIG
Tosoh Corp.
Immunology · 87d
Cleared Dec 23, 2002
ST AIA-PACK CA 19-9
K023240 · NIG
Tosoh Corp.
Immunology · 87d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · DHX
Tosoh Medics, Inc.
Immunology · 26d
Cleared Dec 17, 2002
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · LTJ
Bayer Diagnostics Corp.
Immunology · 167d
Cleared Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA...
K022288 · LTJ
Bayer Corp.
Immunology · 155d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d