JAS HDL CHOLESTEROL (AUTOMATED) REAGENT


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K021671
Device Name JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
Original Applicant
JAS Diagnostics, Inc.
7220 nw 58th st.
miami, 
FL 
33166

Original Contact david johnston
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIX   JJY  
Date Received 05/21/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No