Device Classification Name |
Nephelometer, For Clinical Use
|
510(k) Number |
K962294 |
Device Name |
IMMAGE IMMUNOCHEMISTRY SYSTEM |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. |
W-337 |
BREA,
CA
92821 -6208
|
|
Applicant Contact |
SHERI HALL |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. |
W-337 |
BREA,
CA
92821 -6208
|
|
Correspondent Contact |
SHERI HALL |
Regulation Number | 862.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/1996 |
Decision Date | 08/21/1996 |
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
|
|
|