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
409–432 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 07, 2010
ELECSYS IGE CALCHECK 5
K102269 · JJX
Roche Diagnostics
Immunology · 59d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX
Roche Diagnostics Corp.
Immunology · 141d
Cleared Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
K101809 · JJY
Fujirebio Diagnostics,Inc.
Immunology · 98d
Cleared Oct 05, 2010
ELECSYS CEA CALCHECK 5
K101856 · JJX
Roche Diagnostics
Immunology · 96d
Cleared Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K093107 · DHB
Siemens Healthcare Diagnostics
Immunology · 364d
Cleared Sep 13, 2010
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST...
K100017 · OSK
Euroimmun Us, Inc.
Immunology · 252d
Cleared Sep 03, 2010
SPAPLUS ANALYZER
K100455 · DBI
The Binding Site
Immunology · 198d
Cleared Sep 02, 2010
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
K091969 · NBO
Euroimmun Us, Inc.
Immunology · 428d
Cleared Sep 02, 2010
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736 · DBM
Euroimmun Us, Inc.
Immunology · 363d
Cleared Aug 31, 2010
AUDIT MICROCV RF/CRP LINEARITY SET
K101226 · JJY
Aalto Scientific, Ltd.
Immunology · 120d
Cleared Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · NHX
Bio-Rad Laboratories
Immunology · 244d
Cleared Aug 16, 2010
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
K100588 · CFN
The Binding Site Group , Ltd.
Immunology · 167d
Cleared Aug 13, 2010
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS...
K093459 · MST
Phadia US, Inc.
Immunology · 280d
Cleared Aug 13, 2010
SPAPLUS
K100179 · CZW
The Binding Site Group , Ltd.
Immunology · 204d
Cleared Jul 01, 2010
ANTI-MUTATED CITRULLINATED VIMENTIN EIA
K092399 · OQZ
Orgentec Diagnostika GmbH
Immunology · 329d
Cleared Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
K100538 · DBF
Roche Diagnostics
Immunology · 117d
Cleared Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845 · MID
Phadia US, Inc.
Immunology · 350d
Cleared Jun 03, 2010
AESKU PR3
K091859 · MOB
Aesku Diagnostics
Immunology · 349d
Cleared May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · MSV
Instrumentation Laboratory CO
Immunology · 359d
Cleared May 18, 2010
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · JZO
Diagnostic Hybrids, Inc.
Immunology · 299d
Cleared Mar 18, 2010
TINA-QUANT CERULOPLASMIN
K091741 · CHN
Roche Diagnostics
Immunology · 275d
Cleared Mar 18, 2010
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS...
K093957 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 85d
Cleared Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · MID
Instrumentation Laboratory CO
Immunology · 233d
Cleared Mar 10, 2010
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520 · MVM
Immco Diagnostics, Inc.
Immunology · 292d