| Device Classification Name |
enzyme immunoassay, opiates |
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|---|---|---|---|---|
| 510(k) Number | K992111 | |||
| Device Name | VERDICT -II OPIATES 2000 | |||
| Applicant |
|
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| Correspondent |
|
|||
| Regulation Number | 862.3650 | |||
| Classification Product Code |
|
|||
| Date Received | 06/22/1999 | |||
| Decision Date | 12/16/1999 | |||
| 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 |