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
1729–1752 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Aug 15, 1995
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
K953261 · DHR
Shared Systems, Inc.
Immunology · 34d
Cleared Aug 14, 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · DDR
Princeton BioMeditech Corp.
Immunology · 103d