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Document Number | K100051 |
Test Name | Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test |
Manufacturer Name | ALFA SCIENTIFIC DESIGNS, INC. |
Consumer Information Phone Number | (901)922-5445 |
Test Type | Oxycodone |
Effective Date | 06/17/2011 |
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Device Classification Name |
enzyme immunoassay, opiates
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510(k) Number |
K100051 |
Device Name |
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) |
Applicant |
ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. |
POWAY,
CA
92064
|
|
Applicant Contact |
NASISHU WANG |
Correspondent |
ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. |
POWAY,
CA
92064
|
|
Correspondent Contact |
NASISHU WANG |
Regulation Number | 862.3650
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Classification Product Code |
|
Subsequent Product Code |
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Date Received | 01/08/2010 |
Decision Date | 07/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
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Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
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