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
1297–1320 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 03, 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · NBW
Taidoc Technology Corporation
Chemistry · 291d
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO...
K121987 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 26d
Cleared Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
K121053 · LPS
Diazyme Laboratories
Chemistry · 116d
Cleared Jul 27, 2012
EON CHOLESTEROL REAGENT
K120202 · CHH
Vital Diagnostics Pty., Ltd.
Chemistry · 186d
Cleared Jul 27, 2012
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
K113307 · LFR
Hmd Biomedical, Inc.
Chemistry · 262d
Cleared CT Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
K121190 · LFR
Bayer Healthcare, LLC
Chemistry · 98d
Cleared Jul 26, 2012
A/C ENZYMATIC VITAMIN B6 ASSAY
K111260 · CDD
Anticancer, Inc.
Chemistry · 448d
Cleared Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
K121557 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Jul 24, 2012
CONE-TROL LIQUID CHEMISTRY CONTROLS
K121759 · JJY
Cone Bioproducts
Chemistry · 39d
Cleared Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3...
K113546 · MRG
Roche Diagnostics
Chemistry · 236d
Cleared Jul 23, 2012
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE...
K121907 · CJO
Siemens Healthcare Diagnostics
Chemistry · 24d
Cleared Jul 19, 2012
ACE ALT REAGENT
K113382 · CKA
Alfa Wassermann
Chemistry · 246d
Cleared Jul 17, 2012
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101 · JHI
Polymed Therapeutics, Inc.
Chemistry · 361d
Cleared Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT...
K113374 · CIX
Alfa Wassermann Diagnostic...
Chemistry · 240d
Cleared Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · NBW
Infopia Co, Ltd.
Chemistry · 256d
Cleared Jul 12, 2012
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
K113436 · CJE
Alfa Wassermann
Chemistry · 234d
Cleared Jul 11, 2012
LIQUICHEK URINE CHEMISTRY CONTROL
K121794 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 22d
Cleared Jul 11, 2012
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
K121746 · JJX
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jul 10, 2012
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
K121133 · NBW
I-Sens, Inc.
Chemistry · 88d
Cleared Jul 06, 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649 · NBW
Apex BioTechnology Corp.
Chemistry · 126d
Cleared Jul 03, 2012
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122 · DIF
Biochemical Diagnostic, Inc.
Chemistry · 81d
Cleared Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C,...
K113262 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 242d
Cleared Jul 02, 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL...
K113435 · KHS
Alfa Wassermann
Chemistry · 224d
Cleared CT Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
K121087 · NBW
Bayer Healthcare
Chemistry · 79d