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
937–960 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579 · JJY
Bio-Rad
Immunology · 35d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325 · DBI
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326 · CZW
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334 · JIT
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
PHASE II GBM IGG ANTIBODY EIA TEST
K011348 · MVJ
Scimedx Corp.
Immunology · 54d
Cleared Jun 18, 2001
IBD-CHEK
K011396 · DEG
Techlab, Inc.
Immunology · 42d
Cleared Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL...
K011494 · JJY
Bio-Rad
Immunology · 24d
Cleared Jun 06, 2001
TPO IGG ANTIBODY EIA TEST
K011082 · JZO
Scimedx Corp.
Immunology · 57d
Cleared May 30, 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · JZO
American Laboratory Products Co., Ltd.
Immunology · 22d
Cleared May 24, 2001
ALPCO MILENIA ANTI-TPO ELISA
K011201 · JZO
American Laboratory Products Co., Ltd.
Immunology · 35d
Cleared May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733 · NBT
Inova Diagnostics, Inc.
Immunology · 441d
Cleared May 18, 2001
TINA-QUANT ALPHA-1 ANTITRYPSIN
K010978 · DEM
Rochdiag
Immunology · 66d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079 · DCK
Kamiya Biomedical Co.
Immunology · 37d
Cleared May 15, 2001
RANDOX IGE
K010855 · DGC
Randox Laboratories, Ltd.
Immunology · 54d
Cleared May 10, 2001
CRP HS TEST SYSTEM
K003400 · DCN
Roche Diagnostics Corp.
Immunology · 190d
Cleared May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · JIS
Beckman Coulter, Inc.
Immunology · 63d
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · DDG
Roche Diagnostics Corp.
Immunology · 211d
Cleared Apr 26, 2001
FREELITE LAMBDA FREE KIT
K010440 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
FREELITE KAPPA FREE KIT
K010441 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · LTJ
bioMerieux, Inc.
Immunology · 57d
Cleared Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
K010625 · MVM
Scimedx Corp.
Immunology · 53d
Cleared Apr 11, 2001
VIGIL DNASE B CONTROL
K010693 · JJX
Beckman Coulter, Inc.
Immunology · 34d
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC
Corgenix, Inc.
Immunology · 346d