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
2089–2112 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 20, 2007
JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K071393 · NBW
Agamatrix
Chemistry · 60d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · CEW
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Jul 13, 2007
TRILOGY ANALYZER
K070704 · CGA
Drew Scientific, Inc.
Chemistry · 122d
Cleared Jul 13, 2007
I-CHROMA CRP TEST
K062981 · DCN
Boditech Diagnostics, Inc.
Chemistry · 287d
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