Device Classification Name |
System, Test, Low Density, Lipoprotein
|
510(k) Number |
K014103 |
Device Name |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Applicant Contact |
MARY BETH TANG |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Correspondent Contact |
MARY BETH TANG |
Regulation Number | 862.1475
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2001 |
Decision Date | 01/28/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|