Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
2449–2472 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 07, 1988
QLIA IMMUNOCHEMISTRY SYSTEM
K883349 · JZT
Bd Becton Dickinson Vacutainer...
Immunology · 29d
Cleared Sep 07, 1988
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355 · DHR
United Biotech, Inc.
Immunology · 29d
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