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
2833–2856 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 03, 1985
IMMUNO-IM
K853105 · KTN
Immunostics Co., Inc.
Immunology · 42d
Cleared Aug 28, 1985
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · DGC
Diagnostic Products Corp.
Immunology · 50d
Cleared Aug 28, 1985
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
K853048 · DER
Photec Diagnostics, Inc.
Immunology · 40d
Cleared Aug 22, 1985
IMAGE-IGE
K853025 · DGC
Clinical Reference Laboratory, Inc.
Immunology · 35d
Cleared Aug 22, 1985
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
K853174 · MSJ
Photec Diagnostics, Inc.
Immunology · 23d
Cleared Aug 22, 1985
LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
K853261 · CZS
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Aug 22, 1985
MONOSTICON UNI-DOT
K853388 · KTN
Organon, Inc.
Immunology · 9d
Cleared Aug 01, 1985
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
K852840 · LJM
Modern Diagnostics, Inc.
Immunology · 27d
Cleared Aug 01, 1985
RF CARD TEST
K853054 · DHR
Preco, Inc.
Immunology · 13d
Cleared Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · GTZ
Quidel Corp.
Immunology · 27d
Cleared Jul 19, 1985
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
K851891 · LOJ
Richard Scott Elliott
Immunology · 80d
Cleared Jul 19, 1985
FISHER DIAGNOSTIC LATEST ASO TEST KIT
K852701 · GTQ
Allied Fisher Scientific
Immunology · 23d
Cleared Jul 15, 1985
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · DEW
Coulter Electronics, Inc.
Immunology · 90d
Cleared Jul 15, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · DHB
Pharmacia, Inc.
Immunology · 56d
Cleared Jul 15, 1985
QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)
K852418 · JJY
Amf Biological and Diagnostics Co.
Immunology · 38d
Cleared Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · DEW
Abbott Laboratories
Immunology · 27d
Cleared Jul 15, 1985
ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS
K852718 · HTD
The Huxley Instrument Corp.
Immunology · 19d
Cleared Jul 12, 1985
GONI-KIT
K852582 · JSX
Culture Kits, Inc.
Immunology · 24d
Cleared Jul 10, 1985
APO B RIA KIT
K851389 · MSJ
Iso-Tex Diagnostics
Immunology · 92d
Cleared Jul 10, 1985
ANA/LITE-RL TEST SYSTEM
K852230 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
ANA/LITE-HEP-2 TEST SYSTEM
K852231 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · DDB
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Jul 10, 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · DGC
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Jul 02, 1985
CORDIA S4 -TREPONEMA PALLIDUM
K850329 · LIP
Cordis Corp.
Immunology · 155d