Device Classification Name |
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
|
510(k) Number |
K802245 |
Device Name |
7 TRICYCLIC ANTIDE PRESSANTS |
Applicant |
TECHNICON INSTRUMENTS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TECHNICON INSTRUMENTS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.3910
|
Classification Product Code |
|
Date Received | 09/16/1980 |
Decision Date | 10/10/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|