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
1801–1824 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Feb 23, 1995
IMMULITE(R) ALLERGY FOOD PANEL FP5E
K943194 · DGO
Diagnostic Products Corp.
Immunology · 233d
Cleared Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
K946120 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d