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
889–912 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 02, 2015
Total Bilirubin
K150510 · CIG
Abbott Laboratories
Chemistry · 34d
Cleared Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
K142723 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 189d
Cleared Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
K143324 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 131d
Cleared Mar 26, 2015
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO...
K150052 · NBW
Nipro Diagnostics, Inc.
Chemistry · 73d
Cleared Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 203d
Cleared Mar 13, 2015
Liquichek Maternal Serum II Control
K143379 · JJY
Bio-Rad Laboratories
Chemistry · 108d
Cleared CT Mar 13, 2015
HOME ACCESS AIC TEST
K141944 · LCP
Home Access Health Corp.
Chemistry · 239d
Cleared Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · NBW
Roche Diagnostics
Chemistry · 236d
Cleared Feb 26, 2015
NIOX VERO Airway Inflammation Monitor
K150233 · MXA
Aerocrine AB
Chemistry · 24d
Cleared Feb 26, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K150162 · LAF
W.H.P.M., Inc.
Chemistry · 31d
Cleared Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000...
K143373 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 93d
Cleared Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON...
K142985 · JIT
Beckman Coulter, Inc.
Chemistry · 133d
Cleared Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE...
K143636 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 65d
Cleared Feb 19, 2015
ORAGENE DX OGD-500.001
K141410 · OYJ
DNA Genotek, Inc.
Chemistry · 266d
Not Cleared Feb 19, 2015
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
DEN140044 · PKB
23AndMe
Chemistry · 266d
Cleared Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
K143691 · LBR
Roche Diagnostics Operations (Rdo)
Chemistry · 35d
Cleared Jan 27, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone...
K143187 · DJG
Healgen Scientific, LLC
Chemistry · 83d
Cleared Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
K143571 · JJX
Aalto Scientific, Ltd.
Chemistry · 37d
Not Cleared Jan 23, 2015
Dexcom Share Direct Secondary Displays
DEN140038 · PJT
Dexcom, Inc.
Chemistry · 39d
Cleared Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
K143504 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 29d
Cleared Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D...
K141114 · MRG
Bio-Rad Laboratories
Chemistry · 254d
Cleared Jan 08, 2015
TIVA
K142946 · JKA
Velano Vascular, Inc.
Chemistry · 90d
Cleared Jan 07, 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity...
K141689 · DCK
Qualigen, Inc.
Chemistry · 198d