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
2977–3000 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 07, 1984
PHARMACIA IGE RIA
K841824 · DGC
Pharmacia, Inc.
Immunology · 36d
Cleared Jun 07, 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · DGC
Pharmacia, Inc.
Immunology · 35d
Cleared Jun 07, 1984
ALLERCOAT ALLERGEN DISCS
K842125 · DGC
Kallestad Laboratories, Inc.
Immunology · 9d
Cleared Jun 01, 1984
SERUM COMPLEMENT ACTIVITY TEST-SCAT
K841541 · DAK
Collaborative Research, Inc.
Immunology · 46d
Cleared Jun 01, 1984
VAST VENTREX RAST ALL
K841651 · DGC
Ventrex Laboratories, Inc.
Immunology · 42d
Cleared Jun 01, 1984
TAGO FIFFU-GEN, OROSOMUCOID
K841734 · LKL
Tago, Inc.
Immunology · 36d
Cleared Jun 01, 1984
OPTIMATE IGA TEST
K841815 · CZN
Miles Laboratories, Inc.
Immunology · 31d
Cleared May 25, 1984
DSL FERRITIN IRMA
K841925 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 15d
Cleared May 21, 1984
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · DER
Ventrex Laboratories, Inc.
Immunology · 87d
Cleared May 21, 1984
VENTREXYME EIA CONTROLS IMMUNOASSAY
K841456 · JIX
Vxr, Inc.
Immunology · 42d
Cleared May 11, 1984
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
K834218 · MSJ
Tago, Inc.
Immunology · 155d
Cleared May 11, 1984
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
K840867 · DEI
Intl. Diagnostic Technology
Immunology · 74d
Cleared May 11, 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · DHB
Ventrex Laboratories, Inc.
Immunology · 29d
Cleared Apr 25, 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · DHN
Electro-Nucleonics Laboratories, Inc.
Immunology · 40d
Cleared Apr 25, 1984
RF TEST KIT
K841454 · DHR
Difco Laboratories, Inc.
Immunology · 16d
Cleared Apr 20, 1984
NCS RA LATEX TEST
K841146 · DHR
Ncs Diagnostics, Inc.
Immunology · 35d
Cleared Apr 19, 1984
ANTI-NATIVE DNA ANTIBODY
K834349 · KTL
Sigma Chemical Co.
Immunology · 128d
Cleared Apr 05, 1984
LEAP MONO TEST KIT
K840822 · KTN
Cooper Biomedical, Inc.
Immunology · 41d
Cleared Apr 05, 1984
SOMAS HUMAN SPINAL FLUID CONTROL
K840974 · DFI
Somas Medical Industries, Inc.
Immunology · 30d
Cleared Apr 04, 1984
ANA APPLELISA
K834241 · DHN
Apple Diagnostic Products
Immunology · 120d
Cleared Apr 04, 1984
MAST INHALANT PROFILE
K834526 · DHB
Mast Immunosystems
Immunology · 105d
Cleared Apr 04, 1984
SENSIBEAD EIA IGE KIT
K840674 · DGC
Terumo Medical Corp.
Immunology · 49d
Cleared Apr 04, 1984
SERATEST RF LATEX DETERMINATION
K840863 · DHR
Seragen Diagnostics, Inc.
Immunology · 40d
Cleared Apr 02, 1984
AMIKACIN REAGENT TEST KIT
K840647 · LDN
Beckman Instruments, Inc.
Immunology · 47d