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
2377–2400 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 27, 1989
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K890530 · DGC
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
K891098 · DBL
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)
K891099 · DBL
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Mar 22, 1989
TITAN GEL IFE TRIVALENT ANTISERUM
K891188 · CFQ
Helena Laboratories
Immunology · 16d
Cleared Mar 22, 1989
MID-LEVEL IGG KIT CAT. NO. 9315
K891299 · DAQ
Helena Laboratories
Immunology · 9d
Cleared Mar 16, 1989
BETA-2 MICROGLOBULIN EIA
K890694 · JZG
Serex, Inc.
Immunology · 34d
Cleared Mar 16, 1989
RIA-GNOST FERRITIN
K890697 · JMG
Cambridge Medical Technology
Immunology · 34d
Cleared Mar 16, 1989
MONO-CUBE(TM)
K890991 · KTN
Difco Laboratories, Inc.
Immunology · 17d
Cleared Mar 16, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
K891154 · MSJ
Atlantic Antibodies
Immunology · 10d
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421 · JZG
Abbott Laboratories
Immunology · 42d
Cleared Mar 08, 1989
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
K885307 · DGC
Alerchek, Inc.
Immunology · 71d
Cleared Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675 · CZW
Unipath , Ltd.
Immunology · 25d
Cleared Mar 03, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
K890563 · DDG
Atlantic Antibodies
Immunology · 38d
Cleared Feb 23, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
K890561 · CFQ
Atlantic Antibodies
Immunology · 30d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · DEW
Atlantic Antibodies
Immunology · 29d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · DAD
Atlantic Antibodies
Immunology · 29d
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501 · DHB
Quidel Corp.
Immunology · 114d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415 · DEM
Atlantic Antibodies
Immunology · 24d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR C3
K890417 · KTQ
Atlantic Antibodies
Immunology · 24d
Cleared Feb 17, 1989
V-TREND TARGET CRP TEST
K890423 · DCK
Texas Immunology, Inc.
Immunology · 22d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K890564 · DBI
Atlantic Antibodies
Immunology · 24d
Cleared Feb 15, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · CZP
Atlantic Antibodies
Immunology · 22d
Cleared Feb 07, 1989
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
K885269 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 47d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180 · DHR
Unipath , Ltd.
Immunology · 126d