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
2425–2448 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · LKJ
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
K884074 · DAH
Orion Diagnostica, Inc.
Immunology · 30d
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