Device Classification Name |
enzyme immunoassay, cannabinoids
|
510(k) Number |
K955677 |
Device Name |
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 S. KRAEMER BLVD., W-337 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
SHERI HALL |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 S. KRAEMER BLVD., W-337 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
SHERI HALL |
Regulation Number | 862.3870
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/15/1995 |
Decision Date | 04/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|