Device Classification Name |
system, test, rheumatoid factor
|
510(k) Number |
K971788 |
Device Name |
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR |
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 | 866.5775
|
Classification Product Code |
|
Date Received | 05/14/1997 |
Decision Date | 06/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|