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: Chemistry ×
13,237 results
2353–2376 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 24, 2006
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR...
K052520 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 222d
Cleared Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
K060774 · CGN
Beckman Coulter, Inc.
Chemistry · 30d
Cleared Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · JIN
Abbott Diabetes Care, Inc.
Chemistry · 30d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 14, 2006
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
K060359 · JIT
Denka Seiken Co., Ltd.
Chemistry · 60d
Cleared Apr 14, 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE...
K053577 · MMI
Dade Behring, Inc.
Chemistry · 113d
Cleared Apr 14, 2006
G4, MODEL IGM-0004
K051651 · NBW
U. S. Diagnostics, Inc.
Chemistry · 297d
Cleared Apr 13, 2006
HEMOGLOBIN ALC CONTROL
K060570 · JJX
Compass Bioscience
Chemistry · 38d
Cleared Apr 12, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K060470 · NBW
Bayer Healthcare
Chemistry · 48d
Cleared Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · CDD
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Apr 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · LCP
Ortho-Clinical Diagnostics, Inc.
Chemistry · 24d
Cleared Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
K060628 · CIG
Dade Behring, Inc.
Chemistry · 28d
Cleared Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK...
K060548 · DHA
Dade Behring, Inc.
Chemistry · 36d
Cleared Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385 · MLM
Dade Behring, Inc.
Chemistry · 51d
Cleared Apr 05, 2006
PTS PANELS HDL CHOLESTEROL TEST STRIPS
K060617 · NAQ
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Mar 31, 2006
RX IMOLA
K052914 · CEM
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · LPS
Dade Behring, Inc.
Chemistry · 177d
Cleared Mar 29, 2006
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
K052525 · JIL
DFI Co., Ltd.
Chemistry · 196d
Cleared Mar 29, 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS &...
K050945 · DIO
Lin-Zhi International, Inc.
Chemistry · 349d
Cleared Mar 28, 2006
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
K053079 · CGA
Hypoguard USA, Inc.
Chemistry · 146d
Cleared Mar 27, 2006
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120 · CDQ
Teco Diagnostics
Chemistry · 69d
Cleared Mar 24, 2006
ALBU TROL, LOW, MODEL 108.001.002
K060215 · JJX
Eurotrol B.V.
Chemistry · 56d
Cleared Mar 24, 2006
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
K053401 · CIC
Arkray, Inc.
Chemistry · 108d
Cleared Mar 21, 2006
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC...
K060322 · JIT
Cliniqa Corporation
Chemistry · 40d