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
1009–1032 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Feb 05, 2014
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K133550 · JJX
Maine Standards Company, LLC
Chemistry · 78d
Cleared Jan 29, 2014
UA-CELLULAR COMPLETE
K131444 · JJW
Streck
Chemistry · 254d
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 157d
Cleared Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
K131244 · CEC
Roche Diagnostics
Chemistry · 271d
Cleared Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 49d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · LCP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Jan 23, 2014
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
K131580 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 237d
Cleared Jan 22, 2014
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
K133960 · JJY
Bio-Rad Laboratories
Chemistry · 29d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 17, 2014
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE...
K123517 · NBW
Sd Biosensor
Chemistry · 429d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407 · CHL
Instrumentation Laboratory CO
Chemistry · 68d
Cleared Jan 09, 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · JHI
Polymed Therapeutics, Inc.
Chemistry · 121d
Cleared Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554 · JJE
Randox Laboratories, Ltd.
Chemistry · 224d
Cleared Jan 09, 2014
ACTIM PROM
K123986 · OAM
Alere Scarborough, Inc.
Chemistry · 379d
Cleared Jan 06, 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · NBW
ACON Laboratories, Inc.
Chemistry · 230d
Cleared Jan 03, 2014
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL...
K132399 · JFY
Elitechgroup
Chemistry · 155d
Cleared Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM...
K133512 · CDD
Siemens Healthcare Diagnostics
Chemistry · 48d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Dec 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS...
K123763 · CIB
Immunodiagnostic Systems , Ltd.
Chemistry · 382d
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW
ACON Laboratories, Inc.
Chemistry · 318d
Cleared Dec 20, 2013
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · DKZ
Genprime, Inc.
Chemistry · 340d
Cleared Dec 19, 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · NBW
I-Sens, Inc.
Chemistry · 50d
Cleared Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · JIT
Biokit, S.A.
Chemistry · 140d