DIAZYME LITHIUM ENZYMATIC ASSAY KIT


Device Classification Name

atomic absorption, lithium

510(k) Number K033360
Device Name DIAZYME LITHIUM ENZYMATIC ASSAY KIT
Applicant
GENERAL ATOMICS
3550 general atomics court
san diego, 
CA 
92121

Applicant Contact chong yuan
Correspondent
GENERAL ATOMICS
3550 general atomics court
san diego, 
CA 
92121

Correspodent Contact chong yuan
Regulation Number 862.3560
Classification Product Code
JII  
Date Received 10/21/2003
Decision Date 12/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No