CHOLESITE TEST SYSTEM


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K992132
Device Name CHOLESITE TEST SYSTEM
Applicant
GDS TECHNOLOGY, LLC.
25235 leer dr.
elkhart, 
IN 
46514

Applicant Contact keith crawford
Correspondent
GDS TECHNOLOGY, LLC.
25235 leer dr.
elkhart, 
IN 
46514

Correspodent Contact keith crawford
Regulation Number 862.1175
Classification Product Code
CHH  
Date Received 06/23/1999
Decision Date 08/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No