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
2521–2544 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Feb 25, 1988
PROGENE(TM) IGE TEST
K875125 · DHB
Progene Corp.
Immunology · 72d
Cleared Feb 25, 1988
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001 · DHB
3M Company
Immunology · 52d
Cleared Feb 25, 1988
MODIFIED CRP LATEX TEST
K880016 · DCK
Sclavo, Inc.
Immunology · 51d
Cleared Feb 17, 1988
RRT TOTAL IGE TEST KIT
K874541 · DGC
Incstar Corp.
Immunology · 106d
Cleared Feb 17, 1988
FLIPSCREEN QAT
K874802 · DHB
Alerchek, Inc.
Immunology · 86d
Cleared Feb 17, 1988
MAT (TM) MICROALBUMIN TEST
K875161 · DCF
Wampole Laboratories
Immunology · 64d
Cleared Feb 17, 1988
GULLSORB IGG INACTIVATION REAGENT
K875254 · DEW
Gull Laboratories, Inc.
Immunology · 57d
Cleared Feb 17, 1988
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · DHB
Incstar Corp.
Immunology · 55d
Cleared Feb 17, 1988
QM300 CALIBRATOR B PACK
K875282 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 55d
Cleared Feb 17, 1988
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
K880002 · DHB
3M Company
Immunology · 44d
Cleared Feb 17, 1988
N-IMMUNOGLOBULIN LIGHT CHAIN KIT
K880341 · DFH
Behring Diagnostics, Inc.
Immunology · 22d
Cleared Feb 17, 1988
V-TREND IM DRY-SPOT TEST
K880399 · KTN
Texas Immunology, Inc.
Immunology · 19d
Cleared Feb 10, 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · DHN
Diagnostic Products Corp.
Immunology · 72d
Cleared Feb 10, 1988
LIPOGEN ANA TEST KIT
K875246 · LJM
Lipogen, Inc.
Immunology · 50d
Cleared Feb 10, 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
K875281 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
QM2/QM300 CONTROL B PACK
K875283 · DEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
IMMUNOGLOBULIN G & G SUBCLASSES
K875356 · DEW
Birmingham
Immunology · 41d
Cleared Feb 10, 1988
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
K880148 · KTN
Ampcor, Inc.
Immunology · 28d
Cleared Feb 10, 1988
RF CARD TEST & RF LIQUID TEST
K880164 · DHR
Ampcor, Inc.
Immunology · 28d
Cleared Jan 29, 1988
ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT
K875066 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 51d
Cleared Jan 27, 1988
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203 · DBF
Amersham Corp.
Immunology · 104d
Cleared Jan 22, 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
K875164 · DFH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · DEH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d