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
2641–2664 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Mar 17, 1987
DNP EIA DIAGNOSTIC KIT
K870456 · LJM
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 17, 1987
RNP EIA DIAGNOSTIC KIT
K870457 · LJM
Biohytech International, Inc.
Immunology · 55d