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510(k) K033360

Device
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
Applicant
GENERAL ATOMICS
510(k) number
K033360
Product code
JII  
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-23
Date received
2003-10-21
Regulation
862.3560
Classification name
Atomic Absorption, Lithium
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHONG YUAN
Address
3550 General Atomics Ct. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JII  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDiazyme Laboratories2008-12-05
K912244UROTEST GPHIn Wha Pharmaceutical Co., Ltd.1991-11-22

Legacy Summary#

summary

FDA Review#

Decision Summary