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
2425–2448 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 27, 1988
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY
K884185 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 23d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · KTN
Unipath , Ltd.
Immunology · 62d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
K883915 · DBL
Immco Diagnostics, Inc.
Immunology · 33d
Cleared Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
K884040 · CZP
Orion Diagnostica, Inc.
Immunology · 23d
Cleared Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
K884075 · DDG
Orion Diagnostica, Inc.
Immunology · 22d
Cleared Oct 19, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Oct 18, 1988
QUIDEL ALLERGY SCREEN
K883666 · DHB
Quidel Corp.
Immunology · 53d
Cleared Sep 22, 1988
NOVA LITE(TM) SA
K881341 · LLL
Inova Diagnostics, Inc.
Immunology · 177d
Cleared Sep 22, 1988
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
K882740 · LKJ
Lipogen, Inc.
Immunology · 83d
Cleared Sep 22, 1988
QM300 CALIBRATOR D PACK
K883001 · CZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
QM300 PREALBUMIN ANTIBODY PACK
K883002 · JZJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 66d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492 · CZP
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN M
K883493 · DFL
Technicon Instruments Corp.
Immunology · 37d
Cleared Sep 22, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · DCN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 36d
Cleared Sep 22, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · DHB
Diagnostic Products Corp.
Immunology · 29d
Cleared Sep 22, 1988
QM300 CALIBRATOR F PACK
K883711 · DFC
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Sep 22, 1988
QM300 CONTROL F PACK
K883712 · DFC
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d
Cleared Sep 07, 1988
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
K882998 · DCK
Amtec Diagnostics International, Inc.
Immunology · 51d
Cleared Sep 07, 1988
HISTONE REACTIVE ANA
K883232 · LLL
Val Tech Diagnostics, Inc.
Immunology · 37d
Cleared Sep 07, 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273 · DHB
3M Company
Immunology · 35d
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