Device Classification Name |
system, test, c-reactive protein
|
510(k) Number |
K021572 |
Device Name |
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP 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 | 866.5270
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/14/2002 |
Decision Date | 07/19/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|