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
1801–1824 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 17, 1995
AUTOSTAT II ANTI-TPO
K943580 · JNL
Cogent Diagnotics , Ltd.
Immunology · 269d
Cleared Apr 17, 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · LRM
Elias U.S.A., Inc.
Immunology · 223d
Cleared Apr 17, 1995
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
K951013 · CFQ
Olympus America, Inc.
Immunology · 42d
Cleared Apr 17, 1995
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
K951055 · CFQ
Olympus America, Inc.
Immunology · 41d
Cleared Apr 17, 1995
VARELISA ANA-4 SCREEN
K951186 · LJM
Elias U.S.A., Inc.
Immunology · 32d
Cleared Apr 17, 1995
VARELISA ANA PROFILE
K951205 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA PARIETAL CELL ANTIBODIES
K951206 · MLE
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA HISTONE ANTIBODIES
K951207 · LJM
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 10, 1995
HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
K950102 · DAY
Kent Laboratories, Inc.
Immunology · 89d
Cleared Mar 29, 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
K950414 · LLL
Hemagen Diagnostics, Inc.
Immunology · 57d
Cleared Mar 27, 1995
N LATEX FERRITIN
K950707 · DBF
Behring Diagnostics, Inc.
Immunology · 40d
Cleared Mar 27, 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · CFQ
Olympus America, Inc.
Immunology · 27d
Cleared Mar 21, 1995
LATEX (K82)
K931746 · DHB
Diagnostic Products Corp.
Immunology · 712d
Cleared Mar 13, 1995
HY-TEC AUTOMATED EIA SYSTEM
K941278 · DHB
Hycor Biomedical, Inc.
Immunology · 361d
Cleared Mar 10, 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · LRM
Elias U.S.A., Inc.
Immunology · 65d
Cleared Mar 09, 1995
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K945280 · DCK
Dupont Medical Products
Immunology · 132d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
K933784 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 06, 1995
DIASTAT ANTI-PR3 (C-ANCA) KIT
K942813 · MOB
Shield Diagnostics, Ltd.
Immunology · 265d
Cleared Mar 06, 1995
DIASTAT ANTI-MPO (PANCA) KIT
K943630 · MOB
Shield Diagnostics, Ltd.
Immunology · 223d
Cleared Mar 06, 1995
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768 · DHB
Diagnostic Products Corp.
Immunology · 216d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
K944191 · DBL
Light Diagnostics
Immunology · 189d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
K944192 · DBL
Light Diagnostics
Immunology · 189d