LDL CHOLESTEROL (AUTOMATED)


Device Classification Name

colorimetric method, lipoproteins

510(k) Number K022519
Device Name LDL CHOLESTEROL (AUTOMATED)
Original Applicant
JAS Diagnostics, Inc.
7220 nw 58th st.
miami, 
FL 
33166

Original Contact david johnston
Regulation Number 862.1475
Classification Product Code
JHM  
Subsequent Product Codes
JIX   JJY   MRR  
Date Received 07/30/2002
Decision Date 09/30/2002
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

Recalls CDRH Recalls