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: Chemistry ×
13,257 results
2377–2400 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Mar 21, 2006
MISSION COMPLETE
K060206 · JJY
Diamond Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429 · JJY
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Mar 13, 2006
FERRITIN CALIBRATOR SET, CATALOG NO. 8203
K053291 · JIT
Reference Diagnostics, Inc.
Chemistry · 108d
Cleared Mar 13, 2006
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
K051596 · NBC
Nanogen, Inc.
Chemistry · 270d