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
2377–2400 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 14, 1989
C REACTIVE PROTEIN LIQUID
K892146 · DCK
Ampcor, Inc.
Immunology · 14d
Cleared Apr 12, 1989
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
K891683 · CZN
Helena Laboratories
Immunology · 21d
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