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
1369–1392 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
K113007 · JQP
Bionime Corporation
Chemistry · 143d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Abbott Laboratories
Chemistry · 230d
Cleared Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION...
K111938 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 221d
Cleared Feb 10, 2012
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL...
K103044 · NBW
Bestgen Biotech Corp.
Chemistry · 484d
Cleared Feb 08, 2012
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
K113343 · NBW
Delbio Incorporation
Chemistry · 86d
Cleared Feb 06, 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD...
K111890 · NBW
Taidoc Technology Corporation
Chemistry · 220d
Cleared Feb 03, 2012
IDS-ISYS INTACT PTH
K103325 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 448d
Cleared Jan 31, 2012
AUDIT MICROCV T-UPTAKE LINEARITY
K112143 · JJX
Aalto Scientific, Ltd.
Chemistry · 189d
Cleared Jan 30, 2012
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
K113764 · JJX
Bionostics, Inc.
Chemistry · 40d
Cleared Jan 27, 2012
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K113524 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Jan 27, 2012
MICRODOT & MICRODOT XTRA
K102383 · NBW
Cambridge Sensors Limited
Chemistry · 522d
Cleared Jan 26, 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · CGA
Apex BioTechnology Corp.
Chemistry · 86d
Cleared Jan 23, 2012
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI...
K113661 · LAF
Lin-Zhi International, Inc.
Chemistry · 41d
Cleared Jan 23, 2012
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
K110534 · JJY
Randox Laboratories Limited
Chemistry · 332d
Cleared Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725 · MRG
DiaSorin, Inc.
Chemistry · 122d
Cleared Jan 20, 2012
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC...
K112161 · KHO
Radiometer Medical Aps
Chemistry · 177d
Cleared Jan 18, 2012
MISSION U500 URINE ANALYZER
K111221 · JIO
ACON Laboratories, Inc.
Chemistry · 261d
Cleared Jan 18, 2012
AG-608N BLOOD GLUCOSE MONITORING SYSTEM
K110017 · NBW
Andon Medical Co., Ltd.
Chemistry · 380d
Cleared Jan 17, 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098 · NBW
Apex BioTechnology Corp.
Chemistry · 90d
Cleared Jan 12, 2012
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL...
K100437 · NBW
Bestgen Biotech Corp.
Chemistry · 694d
Cleared Jan 06, 2012
GLUCOSE TEST SYSTEM
K113137 · NBW
Roche Diagnostics
Chemistry · 74d
Cleared Jan 05, 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955 · KHP
Nova Biomedical Corporation
Chemistry · 93d
Cleared Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269 · CJE
Elitechgroup
Chemistry · 55d