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
1729–1752 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 14, 1995
THERATEST LAB, INC., EL-ANASCR KIT
K954106 · LJM
Theratest Laboratories, Inc.
Immunology · 105d
Cleared Nov 09, 1995
ORGEN TEC ANTI-DSDNA ELISA ASSAY
K953671 · LRM
Orgentec
Immunology · 94d
Cleared Nov 06, 1995
VENTANA BLUE DETECTION KIT
K940424 · DEH
Ventana Medical Systems, Inc.
Immunology · 644d
Cleared Oct 27, 1995
CHEMMATE(TM) KAPPA
K950150 · DFH
Biotek Solutions, Inc.
Immunology · 283d
Cleared Oct 27, 1995
CHEMMATE(TM) UCHL1 (CD45-RO)
K950152 · DFH
Biotek Solutions, Inc.
Immunology · 283d
Cleared Oct 13, 1995
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
K951363 · MID
Immunoprobe, Inc.
Immunology · 203d
Cleared Oct 13, 1995
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639 · DAE
Incstar Corp.
Immunology · 186d
Cleared Oct 04, 1995
CHEMMATE(TM) L26 (CD20)
K950151 · DEH
Biotek Solutions, Inc.
Immunology · 260d
Cleared Oct 02, 1995
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · DHB
Quidel Corp.
Immunology · 228d
Cleared Oct 02, 1995
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · MID
Elias U.S.A., Inc.
Immunology · 200d
Cleared Sep 26, 1995
THERATEST EL-ANA PROFILES TEST SYSTEM
K950716 · LJM
Theratest Laboratories, Inc.
Immunology · 238d
Cleared Sep 15, 1995
CARDIOLIPIN IGG,M,A EIA TEST KIT
K952520 · MID
Immunoprobe, Inc.
Immunology · 106d
Cleared Sep 15, 1995
PRENVAL I
K953652 · JQP
Base Ten Systems, Inc.
Immunology · 39d
Cleared Sep 15, 1995
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY...
K953926 · DCK
International Enzymes, Inc.
Immunology · 31d
Cleared Sep 15, 1995
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN...
K953927 · DCF
International Enzymes, Inc.
Immunology · 31d
Cleared Sep 08, 1995
WAKO AUTOKIT APO A1
K952615 · JHN
Wako Chemicals USA, Inc.
Immunology · 94d
Cleared Sep 01, 1995
QUANTA LITE IGA ACA (HRP)
K953366 · MID
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Aug 29, 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · MID
Inova Diagnostics, Inc.
Immunology · 46d
Cleared Aug 25, 1995
AURAFLEX TG-AB AND TPO-AB
K951320 · JNL
Organon Teknika Corp.
Immunology · 155d
Cleared Aug 25, 1995
AURAFLEX TPO-AB
K952607 · JNL
Organon Teknika Corp.
Immunology · 86d
Cleared Aug 24, 1995
HUMAN C5 RID KITS
K942326 · DAY
Jay H. Geller
Immunology · 468d
Cleared Aug 24, 1995
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
K952253 · LLL
Helix Diagnostics, Inc.
Immunology · 101d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · DHR
Olympus America, Inc.
Immunology · 28d
Cleared Aug 15, 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014 · DHB
Diagnostic Products Corp.
Immunology · 47d