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
1273–1296 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN
Alfa Wassermann Diagnostic...
Chemistry · 268d
Cleared Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
K122141 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 19d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
K113437 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 259d
Cleared Aug 03, 2012
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
K120423 · NBW
Bionime Corporation
Chemistry · 172d
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 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