Device Classification Name |
calculator/data processing module, for clinical use
|
510(k) Number |
K760739 |
Device Name |
ACA DATA MATE ACCESSORY |
Applicant |
E.I. DUPONT DE NEMOURS & CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
E.I. DUPONT DE NEMOURS & CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.2100
|
Classification Product Code |
|
Date Received | 09/29/1976 |
Decision Date | 11/16/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|