Device Classification Name |
Colorimetric Method, Lipoproteins
|
510(k) Number |
K022519 |
Device Name |
LDL CHOLESTEROL (AUTOMATED) |
Applicant |
JAS Diagnostics, Inc. |
7220 NW 58TH ST. |
MIAMI,
FL
33166
|
|
Applicant Contact |
David Johnston |
Correspondent |
JAS Diagnostics, Inc. |
7220 NW 58TH ST. |
MIAMI,
FL
33166
|
|
Correspondent Contact |
David Johnston |
Regulation Number | 862.1475
|
Classification Product Code |
|
Subsequent Product Codes |
|
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
|
|
|