FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
865–888 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 2015
AUTION CHECK PLUS
K142262 · JJW
Quantimetrix Corp.
Chemistry · 239d
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 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