ONTRAK TESTCUP 5 (MODIFICATION)— 510(k) K964355
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K964355 for ONTRAK TESTCUP 5 (MODIFICATION), Substantially Equivalent on 1996-12-13. Applicant: Roche Diagnostic Systems, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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