Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
|
510(k) Number |
K993549 |
Device Name |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR |
Applicant |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Applicant Contact |
RICHARD T ROSS |
Correspondent |
BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 |
BOX 8000 |
BREA,
CA
92822 -8000
|
|
Correspondent Contact |
RICHARD T ROSS |
Regulation Number | 866.5510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/19/1999 |
Decision Date | 02/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|