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
1225–1248 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 02, 1999
ELECSYS IGE CALCHECK
K984419 · JJY
Boehringer Mannheim Corp.
Immunology · 54d
Cleared Jan 29, 1999
APOLIPOPROTEIN A1
K983289 · DER
Abbott Laboratories
Immunology · 133d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
K990026 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 24d
Cleared Jan 28, 1999
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · KTN
Oxoid , Ltd.
Immunology · 184d
Cleared Jan 28, 1999
AUTOSTAT II ANA SCREEN ELISA
K983655 · LJM
Cogent Diagnotics , Ltd.
Immunology · 101d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · DCK
Diagnostic Products Corp.
Immunology · 71d
Cleared Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
K984137 · MVM
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jan 26, 1999
APOB
K983281 · DFC
Abbott Laboratories
Immunology · 130d
Cleared Jan 26, 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K983992 · JZO
Nichols Institute Diagnostics
Immunology · 78d
Cleared Jan 25, 1999
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
K984045 · DHR
Kamiya Biomedical Co.
Immunology · 73d
Cleared Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K984321 · CDD
Ortho-Clinical Diagnostics, Inc.
Immunology · 50d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME...
K984516 · MOB
Zeus Scientific, Inc.
Immunology · 24d
Cleared Dec 28, 1998
AUTOSTAT II ENA SCREEN ELISA
K983921 · LLL
Cogent Diagnotics , Ltd.
Immunology · 54d
Cleared Dec 23, 1998
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · DDR
Olympus Diagnostica GmbH
Immunology · 34d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV
Corgenix, Inc.
Immunology · 161d
Cleared Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173 · MID
Zeus Scientific, Inc.
Immunology · 32d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462 · LLL
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · LKO
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · LKP
Bio-Rad
Immunology · 6d