Device Classification Name |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
|
510(k) Number |
K881498 |
Device Name |
SYNCHRON CX(TM)4 CLINICAL ANALYZER |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
WILLIAM T RYAN |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
WILLIAM T RYAN |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 04/08/1988 |
Decision Date | 06/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|