Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
2521–2544 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 11, 1988
RNP ANTIBODY TEST KIT
K874152 · LKO
Lipogen, Inc.
Immunology · 150d
Cleared Mar 11, 1988
LA ANTIBODY TEST KIT
K874195 · LJM
Lipogen, Inc.
Immunology · 149d
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