| Device Classification Name |
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
|
| 510(k) Number |
K853041 |
| Device Name |
TRIGLYCERIDES LCK 124 |
| Applicant |
| German American Chamber of Commerce, Inc. |
| One Farragut-Sq. S. |
|
Washington,
DC
20006
|
|
| Applicant Contact |
LOTHAR GRIESSBACH |
| Correspondent |
| German American Chamber of Commerce, Inc. |
| One Farragut-Sq. S. |
|
Washington,
DC
20006
|
|
| Correspondent Contact |
LOTHAR GRIESSBACH |
| Regulation Number | 862.1795 |
| Classification Product Code |
|
| Date Received | 07/19/1985 |
| Decision Date | 08/12/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|