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
601–624 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 06, 2006
TECHLAB ASCA-CHEK
K051927 · NBT
Techlab, Inc.
Immunology · 262d
Cleared Mar 31, 2006
ETI-MAX 3000
K052794 · JJF
DiaSorin, Inc.
Immunology · 179d
Cleared Mar 29, 2006
FIDIS CELIAC
K053383 · MST
Biomedical Diagnostics (Bmd) SA
Immunology · 114d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072 · DEM
Dade Behring, Inc.
Immunology · 147d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · DEB
Dade Behring, Inc.
Immunology · 147d
Cleared Mar 16, 2006
N ANTISERA TO HUMAN CERULOPLASMIN
K053074 · DDB
Dade Behring, Inc.
Immunology · 135d
Cleared Mar 16, 2006
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · DDG
Dade Behring, Inc.
Immunology · 135d
Cleared Mar 13, 2006
RDI HSFERRITIN KIT
K053211 · DBF
Reference Diagnostics, Inc.
Immunology · 117d
Cleared Mar 13, 2006
FIDIS CONNECTIVE 10, MODEL MX006
K053653 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 73d
Cleared Mar 13, 2006
COBAS 6000 SERIES SYSTEM
K060373 · CEM
Roche Diagnostics
Immunology · 28d
Cleared Mar 02, 2006
FIDIS VASCULITIS, MODEL MX007
K053012 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 127d
Cleared Feb 23, 2006
FERRITIN LIT ASSAY, CATALOG NO. 7010
K052617 · DBF
Good Biotech Corp.
Immunology · 153d
Cleared Feb 16, 2006
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
K051489 · MOB
Euroimmun Us, LLC
Immunology · 255d
Cleared Feb 13, 2006
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · CZP
Beckman Coulter, Inc.
Immunology · 26d
Cleared Feb 07, 2006
AESKULISA GLIA A AND AESKULISA GLIA G
K052439 · MST
Aesku Diagnostics
Immunology · 154d
Cleared Feb 07, 2006
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS...
K052793 · MST
Pharmacia Diagnostics AB
Immunology · 127d
Cleared Feb 07, 2006
ROCHE ELECSYS ANTI-TG
K053426 · JZO
Roche Diagnostics Corp.
Immunology · 61d
Cleared Feb 07, 2006
EL-ACL SCREEN
K060176 · MID
Theratest Laboratories, Inc.
Immunology · 15d
Cleared Jan 23, 2006
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
K051677 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 216d
Cleared Dec 23, 2005
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · DBF
Kamiya Biomedical Co.
Immunology · 253d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE...
K052819 · DEM
Ortho-Clinical Diagnostics, Inc.
Immunology · 80d
Cleared Dec 20, 2005
VITROS CA 19-9
K052889 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 68d
Cleared Dec 12, 2005
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
K052133 · NHX
Eurodiagnostica
Immunology · 129d
Cleared Nov 23, 2005
IGD DIAGNOSTIC TEST KITS
K051299 · CZJ
The Binding Site, Ltd.
Immunology · 189d