Device Classification Name |
nad reduction/nadh oxidation, cpk or isoenzymes
|
510(k) Number |
K781149 |
Device Name |
CPK-L TUBE |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 07/11/1978 |
Decision Date | 08/14/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|