ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579— 510(k) K994164
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K994164 for ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579, Substantially Equivalent on 2000-04-13. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code LDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
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