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
1393–1416 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 CT 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
Cleared Dec 23, 2011
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD...
K112901 · LFR
Eps Bio Technology Corp.
Chemistry · 81d
Cleared Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
K112412 · CEM
Beckman Coulter, Inc.
Chemistry · 123d
Cleared Dec 23, 2011
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
K110726 · LDP
Roche Diagnostics
Chemistry · 282d