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
2665–2688 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 17, 1987
HISTONES EIA DIAGNOSTIC KIT
K870458 · DHN
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131 · DCK
Abbott Laboratories
Immunology · 146d
Cleared Mar 13, 1987
EZ COMPLEMENT REAGENTS, 78N2212
K870351 · DHL
Diamedix Corp.
Immunology · 43d
Cleared Mar 12, 1987
APO B., IMMUNOTURBIDIMETRIC ASSAY
K864228 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 135d
Cleared Mar 12, 1987
ANA TEST KIT
K864668 · LKJ
Val Tech Diagnostics, Inc.
Immunology · 100d
Cleared Mar 12, 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151 · JJX
3M Company
Immunology · 58d
Cleared Mar 12, 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 30d
Cleared Mar 10, 1987
RAT LIVER NUCLEI TEST SYSTEM
K870732 · DHN
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Mar 04, 1987
D. FARINAE ALLERGEN DISC
K870597 · DHB
Incstar Corp.
Immunology · 21d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
K863868 · DFF
Cooper Biomedical, Inc.
Immunology · 133d
Cleared Feb 13, 1987
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
K864512 · DAD
Cooper Biomedical, Inc.
Immunology · 92d
Cleared Feb 13, 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · DHB
Incstar Corp.
Immunology · 21d
Cleared Feb 12, 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104 · DHB
3M Company
Immunology · 114d
Cleared Feb 12, 1987
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153 · DHB
3M Company
Immunology · 30d
Cleared Feb 10, 1987
AFT(R) HEP PERFORMANCE EVALUATION PROGRAM
K865019
Behring Diagnostics, Inc.
Immunology · 49d
Cleared Feb 10, 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107 · DBF
Diagnostic Products Corp.
Immunology · 29d
Cleared Feb 06, 1987
ALLERGEN SPECIFIC CONTROLS
K870152 · DHB
3M Company
Immunology · 24d
Cleared Feb 02, 1987
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · DDC
Miles Laboratories, Inc.
Immunology · 41d
Cleared Jan 16, 1987
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
K864393 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 71d
Cleared Jan 16, 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437 · DBF
Beckman Instruments, Inc.
Immunology · 65d
Cleared Jan 09, 1987
IC MICROASSAY
K864312 · DAK
Diamedix Corp.
Immunology · 67d
Cleared Jan 09, 1987
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K865014 · DGR
Bio-Rad
Immunology · 17d
Cleared Dec 22, 1986
SPECIFIC IGE FAST(TM) TEST II
K863967 · DHB
3M Company
Immunology · 73d
Cleared Dec 22, 1986
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
K864699 · JZT
Pandex Laboratories, Inc.
Immunology · 20d