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
409–432 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Mar 05, 2010
THERATEST EL-ANTI-CCP/2
K090753 · NHX
Theratest Laboratories, Inc.
Immunology · 350d
Cleared Mar 01, 2010
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
K082823 · CFN
The Binding Site Group , Ltd.
Immunology · 522d