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
3553–3576 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · DJB
Kallestad Laboratories, Inc.
Immunology · 18d
Cleared Mar 17, 1978
RID SYSTEM-HUMAN C-REACTIVE PROTEIN
K780325 · DEN
Icl Scientific
Immunology · 18d
Cleared Feb 28, 1978
LAS-R HUMAN IGD TEST
K772327 · CZJ
Hyland Therapeutic Div., Travenol...
Immunology · 69d
Cleared Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
K780250 · CZX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Feb 13, 1978
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422 · DON
Bio-Rad
Immunology · 47d
Cleared Feb 13, 1978
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178 · DHN
Zeus Scientific, Inc.
Immunology · 10d
Cleared Feb 07, 1978
THYROID STIMULATING HORMONE
K780015 · JLW
Pcl-Ria, Inc.
Immunology · 35d
Cleared Feb 07, 1978
THYRO-INDICATOR T-3 125I
K780018 · CDP
Clinical Immuno-Diagnostics
Immunology · 35d
Cleared Feb 07, 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161 · DHN
Zeus Scientific, Inc.
Immunology · 7d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-COMP. 3
K772073 · DBI
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN
K772074 · DDI
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT
K772075 · DAY
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.
K772076 · CZP
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
K772077 · DEW
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN
K772078 · DAB
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
K772079 · DFL
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
K772080 · DEM
Gelman Instrument Co.
Immunology · 92d
Cleared Feb 03, 1978
LAS-R HUMAN ANTITHROMBIN III TEST
K772328 · JBQ
Hyland Therapeutic Div., Travenol...
Immunology · 44d
Cleared Feb 03, 1978
LAS-R HUMAN PREALBUMIN TEST
K772329 · JZJ
Hyland Therapeutic Div., Travenol...
Immunology · 44d
Cleared Feb 03, 1978
HUMAN FOLLICLE STIMULATING HORMONE
K780016 · CGI
Pcl-Ria, Inc.
Immunology · 31d
Cleared Jan 24, 1978
LAS-R HUMAN C3 PROACTIVATOR TEST
K772084 · JZH
Hyland Therapeutic Div., Travenol...
Immunology · 81d
Cleared Jan 24, 1978
LAS-R HUMAN PLASMINOGEN TEST
K772085 · DDX
Hyland Therapeutic Div., Travenol...
Immunology · 81d
Cleared Jan 20, 1978
INSULIN RIA MODULE
K771947 · CFP
Inter Science Institute
Immunology · 95d
Cleared Jan 20, 1978
GLUCAGON RIA MODULE
K771948 · JME
Inter Science Institute
Immunology · 95d