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
937–960 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · DCK
Beckman Coulter, Inc.
Immunology · 70d
Cleared Apr 03, 2001
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
K010558 · MLE
Inova Diagnostics, Inc.
Immunology · 36d