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
3385–3408 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 14, 1980
ANATON
K801046 · DHN
Armkel, LLC
Immunology · 9d
Cleared May 08, 1980
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · DEW
Icl Scientific
Immunology · 20d
Cleared May 08, 1980
CORDIA N
K800991 · DHC
Cordis Corp.
Immunology · 14d
Cleared May 08, 1980
CORDIA NP
K800992 · DHC
Cordis Corp.
Immunology · 14d
Cleared Apr 24, 1980
GEMENI IGM ASSAY
K800450 · DAO
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 24, 1980
GEMENI IGG ASSAY
K800451 · DEW
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
K800820 · DBE
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · DBM
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 16, 1980
FERRITIN CONTROLS CODE QAS.104
K800657 · DBF
Amersham Corp.
Immunology · 22d
Cleared Mar 12, 1980
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
K800398 · DEW
Diagnostica, Inc.
Immunology · 15d
Cleared Mar 12, 1980
GEMENI IGA ASSAY
K800449 · CZP
Electro-Nucleonics Laboratories, Inc.
Immunology · 12d
Cleared Mar 03, 1980
FERRITIN RIA KIT
K800299 · DBF
Amersham Corp.
Immunology · 21d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · DBL
Kallestad Laboratories, Inc.
Immunology · 66d
Cleared Feb 21, 1980
IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
K800228 · DBE
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · DBM
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 15d
Cleared Feb 19, 1980
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211 · CZP
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 19, 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · CZW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 05, 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · DEW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 05, 1980
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167 · DFT
Calbiochem-Behring Corp.
Immunology · 11d
Cleared Jan 24, 1980
IMMUNODIFFUSION BAND INTENSIFYING FLUID
K792692 · GMK
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
ANTI-GLOBULIN CONTROL
K792695 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NORMAL GLOBULIN REAGENT
K792697 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
OUCHTERLONY AGAR PLATES
K792699 · JZQ
Meridian Diagnostics, Inc.
Immunology · 28d