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
2689–2712 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 15, 1986
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
K863743 · DHB
Immuno Nuclear Corp.
Immunology · 82d
Cleared Dec 15, 1986
ANTI-NDNA ANTIBODY TEST KIT
K864275 · KTL
Cappel Diagnostics, Inc.
Immunology · 47d
Cleared Dec 03, 1986
SANTEST 1AP
K862087 · LKL
Scientific Sales Intl., Inc.
Immunology · 184d
Cleared Dec 03, 1986
IMMPULSE IGE ASSAY REAGENTS
K863327 · DGP
Sclavo, Inc.
Immunology · 98d
Cleared Dec 03, 1986
RAPID SPECIFIC IGE PROCEDURE
K863394 · DHB
Allertec, Inc.
Immunology · 91d
Cleared Dec 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794 · DHB
3M Company
Immunology · 68d
Cleared Dec 03, 1986
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142 · DGC
United Biotech, Inc.
Immunology · 42d
Cleared Dec 03, 1986
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · KTN
Gamma Biologicals, Inc.
Immunology · 37d
Cleared Dec 01, 1986
ELM ALLERGEN DISC
K863973 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Dec 01, 1986
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
K864342 · CFN
Eiken Chemical Co., Inc.
Immunology · 27d
Cleared Nov 12, 1986
ABBOTT B2-MICROGLOBULIN RIA
K864130 · JZG
Abbott Laboratories
Immunology · 22d
Cleared Nov 07, 1986
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K864137 · KIJ
Bio-Rad
Immunology · 17d
Cleared Nov 03, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K861882 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
K861883 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
THE FIAX 5000 FLUOROMETER
K863434 · JZT
Whittaker Bioproducts, Inc.
Immunology · 55d
Cleared Oct 29, 1986
ENZYMUN-TEST(R) IGE
K863822 · DGC
Boehringer Mannheim Corp.
Immunology · 29d
Cleared Oct 29, 1986
IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
K863844 · DHB
Immuno Nuclear Corp.
Immunology · 28d
Cleared Oct 24, 1986
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
K862969 · LJM
Biohytech International, Inc.
Immunology · 79d
Cleared Oct 24, 1986
ANTI-DNA MICROASSAY
K863717 · DHN
Diamedix Corp.
Immunology · 31d
Cleared Oct 15, 1986
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS
K863628 · DCK
Technicon Instruments Corp.
Immunology · 28d
Cleared Oct 15, 1986
MYOLEX
K863730 · DDR
Orion Corp.
Immunology · 22d
Cleared Oct 08, 1986
READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
K863238 · DHR
Biostar Medical Products, Inc.
Immunology · 48d
Cleared Oct 08, 1986
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · DBF
Hybritech, Inc.
Immunology · 40d