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
2113–2136 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 13, 2007
POINTE 360
K062118 · CFR
Pointe Scientific, Inc.,
Chemistry · 353d
Cleared Jul 11, 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960 · CGA
Nova Biomedical Corp.
Chemistry · 97d
Cleared Jul 03, 2007
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
K062377 · NBW
Medapps, Inc.
Chemistry · 322d
Cleared Jun 29, 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS...
K071030 · JHI
Applied Dna Technologies, Inc.
Chemistry · 79d
Cleared Jun 29, 2007
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
K070921 · JHI
Applied Dna Technologies, Inc.
Chemistry · 88d
Cleared Jun 29, 2007
POLYMAP PWR-08-03
K070559 · NBW
Polymap Wireless
Chemistry · 122d
Cleared Jun 28, 2007
SMS GLUCOSE CONTROL, MODEL 2120059
K071433 · JJY
Specialty Medical Supplies
Chemistry · 36d
Cleared Jun 25, 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK...
K070819 · LCP
Bio-Rad Laboratories Inc., Clinical...
Chemistry · 91d
Cleared Jun 25, 2007
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
K063376 · CHL
Medica Corp.
Chemistry · 229d
Cleared Jun 22, 2007
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
K070524 · NBW
Cambridge Sensors Limited
Chemistry · 119d
Cleared Jun 22, 2007
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · JFY
Diagnostic Chemicals , Ltd.
Chemistry · 133d
Cleared Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN...
K071002 · NQD
Beckman Coulter, Inc.
Chemistry · 73d
Cleared Jun 21, 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · NBW
Taidoc Technology Corporation
Chemistry · 78d
Cleared Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
K063605 · CEW
Tosoh Bioscience, Inc.
Chemistry · 199d
Cleared Jun 19, 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM,...
K063232 · CEW
Biokit, S.A.
Chemistry · 237d
Cleared Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · DIC
Dade Behring, Inc.
Chemistry · 77d
Cleared Jun 13, 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · NBW
Nova Biomedical Corp.
Chemistry · 138d
Cleared Jun 12, 2007
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K062737 · CGS
Horiba Abx
Chemistry · 272d
Cleared Jun 05, 2007
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN...
K060434 · CIX
Horiba Abx
Chemistry · 469d
Cleared Jun 04, 2007
OLYMPUS CK-MB REAGENT
K070835 · JHY
Olympus Life & Material Science...
Chemistry · 69d
Cleared Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277 · CGX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
IMDX SYSTEMS
K063699 · DJG
Novx Systems, Inc.
Chemistry · 170d