510(k) K082001

Device: DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
Applicant: DIAZYME LABORATORIES
510(k) number: K082001
Product code: JII
Decision: Substantially Equivalent (SESE)
Decision date: 2008-12-05
Date received: 2008-07-14
Regulation: 862.3560
Classification name: Atomic Absorption, Lithium
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Special
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#

2032900
3004493545

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00817089021259	Diazyme	DIAZYME LABORATORIES, INC.	2016-11-03
00817089020429	Diazyme	DIAZYME LABORATORIES, INC.	2016-11-03
00817089020412	Diazyme	DIAZYME LABORATORIES, INC.	2016-11-03

Other 510(k) Records For Product Code JII #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K033360	DIAZYME LITHIUM ENZYMATIC ASSAY KIT	General Atomics	2003-12-23
K912244	UROTEST GPH	In Wha Pharmaceutical Co., Ltd.	1991-11-22

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