Device Classification Name |
system, hemoglobin, automated
|
510(k) Number |
K020616 |
Device Name |
BAYER RAPIDPOINT 405 SYSTEM |
Applicant |
BAYER DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Applicant Contact |
THOMAS F FLYNN |
Correspondent |
BAYER DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Correspondent Contact |
THOMAS F FLYNN |
Regulation Number | 864.5620
|
Classification Product Code |
|
Date Received | 02/25/2002 |
Decision Date | 07/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|