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
793–816 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · LKP
Bio-Rad
Immunology · 23d
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