Device Classification Name |
Igg, Antigen, Antiserum, Control
|
510(k) Number |
K963974 |
Device Name |
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
ANNETTE HELLIE |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
ANNETTE HELLIE |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 10/02/1996 |
Decision Date | 03/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|