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
1033–1056 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d