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
601–624 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Not Cleared Apr 26, 2006
PHICAL TEST
DEN060001 · NXO
Genova Diagnostics
Immunology · 34d
Cleared Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS...
K060940 · JIX
Ortho-Clinical Diagnostics, Inc.
Immunology · 18d
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