ONTRAK TESTCUP 5, CAT. 07 6481 7— 510(k) K994030
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K994030 for ONTRAK TESTCUP 5, CAT. 07 6481 7, 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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