|
Document Number | K050936 |
Test Name | Acon Laboratories, Inc. On Call Home Drug Test for Marijuana |
Manufacturer Name | ACON LABORATORIES, INC. |
Consumer Information Phone Number | (800)825-9957 |
Test Type | Cannabinoids (THC) |
Effective Date | 06/30/2005 |
| |
Device Classification Name |
enzyme immunoassay, cannabinoids
|
510(k) Number |
K050936 |
Device Name |
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
Applicant |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EDWARD TUNG |
Correspondent |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
EDWARD TUNG |
Regulation Number | 862.3870
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/14/2005 |
Decision Date | 06/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
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