Device Classification Name |
drug specific control materials |
|||
---|---|---|---|---|
510(k) Number | K992151 | |||
Device Name | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | |||
Applicant |
|
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Applicant Contact | e. kay robinson | |||
Correspondent |
|
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Correspodent Contact | e. kay robinson | |||
Regulation Number | 862.3280 | |||
Classification Product Code |
|
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Date Received | 06/24/1999 | |||
Decision Date | 07/14/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Toxicology |
|||
510k Review Panel |
Toxicology |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |