codes
| Device Classification Name |
enzyme immunoassay, opiates |
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|---|---|---|---|---|
| 510(k) Number | K000464 | |||
| Device Name | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A | |||
| Original Applicant |
|
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| Original Contact | judy mcinnis-berger | |||
| Regulation Number | 862.3650 | |||
| Classification Product Code |
|
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| Date Received | 02/11/2000 | |||
| Decision Date | 04/14/2000 | |||
| 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 | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |