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
2449–2472 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 07, 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · MSJ
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN G
K883494 · DAH
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
QM300 CALIBRATOR E PACK
K883538 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Aug 10, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899 · DHB
Diagnostic Products Corp.
Immunology · 96d
Cleared Aug 04, 1988
TECHNICON DPA-1(TM) SYSTEM
K882153 · DCF
Technicon Instruments Corp.
Immunology · 73d
Cleared Aug 04, 1988
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616 · JHR
Pharmacia, Inc.
Immunology · 41d
Cleared Aug 04, 1988
PHARMACIA IGE EIA ULTRA
K882626 · DGC
Pharmacia, Inc.
Immunology · 38d
Cleared Aug 04, 1988
FIAGEN FERRITIN
K882822 · DFL
Cyberfluor, Inc.
Immunology · 27d
Cleared Aug 04, 1988
CIRCULATING IMMUNE COMPLEXES CONTROLS
K882829 · DAK
Cytotech, Inc.
Immunology · 27d
Cleared Aug 04, 1988
MONO-PLUS(TM)
K883004 · KTN
Wampole Laboratories
Immunology · 17d
Cleared Jul 12, 1988
ACCRAASSAY RID KITS
K882369 · DEW
Icn Immunobiologicals
Immunology · 34d
Cleared Jul 12, 1988
STAT-20 FLUOROMETER
K882677 · JZT
Weaver Medical
Immunology · 14d
Cleared Jul 08, 1988
MONOCLONAL RADIAL IMMUNODIFFUSION KIT
K881928 · CFQ
The Binding Site, Ltd.
Immunology · 60d
Cleared Jul 08, 1988
QM300 ALBUMIN ANTIBODY PACK
K882082 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
QM300 IGG ANTIBODY PACK
K882083 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
WAKO(TM) CRP
K882374 · DCN
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Jul 08, 1988
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446 · DEM
Technicon Instruments Corp.
Immunology · 24d
Cleared Jul 08, 1988
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620 · MSJ
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · DBI
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882622 · JFR
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
K882623 · JZH
Technicon Instruments Corp.
Immunology · 14d
Cleared Jun 14, 1988
HOUSE DUST
K875110 · DHB
Incstar Corp.
Immunology · 183d
Cleared Jun 14, 1988
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K881898 · MSJ
Atlantic Antibodies
Immunology · 47d