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
1897–1920 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 21, 1994
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · DGC
Ciba Corning Diagnostics Corp.
Immunology · 209d
Cleared Apr 21, 1994
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · JZG
Beckman Instruments, Inc.
Immunology · 86d
Cleared Apr 20, 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · LLL
Hemagen Diagnostics, Inc.
Immunology · 134d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
K940510 · LKP
Helix Diagnostics, Inc.
Immunology · 75d
Cleared Apr 20, 1994
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
K940588 · LKO
Helix Diagnostics, Inc.
Immunology · 71d
Cleared Mar 30, 1994
VENTANA NEGATIVE CONTROL REAGENT
K931979 · DEM
Ventana Medical Systems, Inc.
Immunology · 342d
Cleared Mar 25, 1994
SYNELISA ANA TOTAL
K935468 · LJM
Elias U.S.A., Inc.
Immunology · 133d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641 · LJM
Elias U.S.A., Inc.
Immunology · 39d
Cleared Mar 22, 1994
N-ASSAY TIA IGM
K933970 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGA
K933971 · CFN
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGG
K933972 · CFF
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · DHB
Diagnostic Products Corp.
Immunology · 127d
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K926420 · DHB
Mast Immunosystems
Immunology · 439d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K934524 · DHB
Mast Immunosystems
Immunology · 168d
Cleared Jan 31, 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · LLL
Immuno Concepts, Inc.
Immunology · 95d
Cleared Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · DHR
Theratest Laboratories, Inc.
Immunology · 182d
Cleared Jan 28, 1994
N-ASSAY TIA MULTI V-NL
K933973 · CFN
Crestat Diagnostics, Inc.
Immunology · 168d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · DBF
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 73d
Cleared Jan 24, 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · MID
Elias U.S.A., Inc.
Immunology · 82d
Cleared Jan 13, 1994
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
K930796 · JZX
Alko Diagnostic Corp.
Immunology · 331d
Cleared Jan 11, 1994
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
K933078 · MGA
Beckman Instruments, Inc.
Immunology · 202d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966 · DDS
Incstar Corp.
Immunology · 88d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075 · DCN
Incstar Corp.
Immunology · 78d