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Document Number | K050878 |
Test Name | Alere Tox Screen Drugs of Abuse Test Cup |
Manufacturer Name | ACON LABORATORIES, INC. |
Consumer Information Phone Number | 1(800)340-4029 |
Test Type | Amphetamines |
Effective Date | 10/02/2014 |
| |
Device Classification Name |
Enzyme Immunoassay, Cannabinoids
|
510(k) Number |
K050878 |
Device Name |
ON CALL MULTI-DRUG HOME TEST CUP |
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 Codes |
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Date Received | 04/06/2005 |
Decision Date | 06/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
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|
|