ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2— 510(k) K994020
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K994020 for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2, Substantially Equivalent on 2000-01-27. Applicant: Roche Diagnostics Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- 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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