510(k) K091455

Device: DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
Applicant: DIAZYME LABORATORIES
510(k) number: K091455
Product code: MZV
Decision: Substantially Equivalent (SESE)
Decision date: 2009-08-14
Date received: 2009-05-18
Regulation: 862.1600
Classification name: Test, System, Potassium, Enzymatic Method
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: Abhijit Datta
Address: 12889 Gregg Ct. Poway CA US 92064 92064

FDA Registration Numbers#

3021841051
3003593973
2032900

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05060500092009	Synermed®	INFRARED LABORATORY SYSTEMS LLC	2017-02-28
05060500091279	Synermed®	INFRARED LABORATORY SYSTEMS LLC	2016-09-20

Other 510(k) Records For Product Code MZV #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K200865	Piccolo Potassium Test System	Abaxis, Inc.	2021-10-20
K053566	MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A	Diazyme Laboratories	2006-02-15
K042191	DIAZYME POTASSIUM ENZYMATIC ASSAY KIT	Diazyme Laboratories	2004-10-29

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary