Device Classification Name |
Enzyme Immunoassay, Amphetamine
|
510(k) Number |
K973784 |
Device Name |
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS |
Applicant |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JOHN F BRUNI |
Correspondent |
BIOSITE INCORPORATED |
11030 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JOHN F BRUNI |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/03/1997 |
Decision Date | 12/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|