| Device Classification Name |
enzyme immunoassay, barbiturate |
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|---|---|---|---|---|
| 510(k) Number | K010959 | |||
| Device Name | VERDICT -II BAR; VERDICT -II BZO | |||
| Original Applicant |
|
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| Original Contact | michael turanchik | |||
| Regulation Number | 862.3150 | |||
| Classification Product Code |
|
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| Subsequent Product Code |
|
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| Date Received | 03/30/2001 | |||
| Decision Date | 04/13/2001 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Toxicology |
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| 510k Review Panel |
Toxicology |
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| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |