Device Classification Name |
enzyme immunoassay, methadone |
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510(k) Number | K023617 | |||
Device Name | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | |||
Original Applicant |
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Original Contact | lakshmi anne | |||
Regulation Number | 862.3620 | |||
Classification Product Code |
|
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Subsequent Product Codes |
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Date Received | 10/29/2002 | |||
Decision Date | 08/27/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Toxicology |
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510k Review Panel |
Toxicology |
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summary |
summary |
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FDA Review | Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |