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
2641–2664 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 14, 1987
WESTERN RAGWEED ALLERGEN DISC
K871660 · DHB
Incstar Corp.
Immunology · 16d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055 · DCK
Boehringer Mannheim Corp.
Immunology · 50d
Cleared May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196 · DHR
Orion Diagnostica, Inc.
Immunology · 43d
Cleared May 01, 1987
IVT SOUTHWEST ALLERGY SCREEN
K870625 · DHB
In Vitro Technologies, Inc.
Immunology · 77d
Cleared Apr 29, 1987
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
K871144 · DHN
Vitrotec Laboratories, Inc.
Immunology · 37d
Cleared Apr 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
K871498 · DFT
Helena Laboratories
Immunology · 13d
Cleared Apr 28, 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · DHB
Ventrex Laboratories, Inc.
Immunology · 25d
Cleared Apr 22, 1987
QM300 IGG ANTIBODY PACK
K871340 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · DEW
Helena Laboratories
Immunology · 16d
Cleared Apr 21, 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · CZW
Dako Corp.
Immunology · 15d
Cleared Apr 20, 1987
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
K871194 · DBL
Cronus
Immunology · 27d
Cleared Apr 20, 1987
DUAL SUBSTRATE ANA
K871395 · DHN
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Apr 14, 1987
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
K870009 · DHB
Ventrex Laboratories, Inc.
Immunology · 102d
Cleared Apr 14, 1987
TOTAL IGE MASTICK
K870966 · DHB
Mast Immunosystems
Immunology · 35d
Cleared Mar 30, 1987
SANASSAY IC TEST
K860996 · DAK
Scientific Sales Intl., Inc.
Immunology · 384d
Cleared Mar 24, 1987
DS-DNA EIA DIAGNOSTIC KIT
K870453 · LJM
Biohytech International, Inc.
Immunology · 62d
Cleared Mar 24, 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K870564 · MSJ
Atlantic Antibodies
Immunology · 42d
Cleared Mar 24, 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624 · DHB
Ventrex Laboratories, Inc.
Immunology · 39d
Cleared Mar 24, 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K870862 · MSJ
Atlantic Antibodies
Immunology · 21d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C3
K870930 · CZM
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C4
K870931 · DBI
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 17, 1987
ALLERG*ENS ENZYME IMMUNOASSAY KIT
K864696 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 106d
Cleared Mar 17, 1987
SS-DNA EIA DIAGNOSTIC KIT
K870452 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
SM EIA DIAGNOSTIC KIT
K870455 · LJM
Biohytech International, Inc.
Immunology · 55d