Device Classification Name |
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
|
510(k) Number |
K934977 |
Device Name |
MODEL 5500 CEAS |
Applicant |
ESA, INC. |
45 WIGGINS AVE. |
BEDFORD,
MA
01730
|
|
Applicant Contact |
JAMES MAYOL |
Correspondent |
ESA, INC. |
45 WIGGINS AVE. |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
JAMES MAYOL |
Regulation Number | 862.1795
|
Classification Product Code |
|
Date Received | 10/19/1993 |
Decision Date | 01/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|