Device Classification Name |
radioimmunoassay, cannabinoid(s)
|
510(k) Number |
K820391 |
Device Name |
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI |
Applicant |
HOFFMANN-LA ROCHE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HOFFMANN-LA ROCHE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3870
|
Classification Product Code |
|
Date Received | 02/10/1982 |
Decision Date | 03/08/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|