REVISED LABELING FOR PCP TEST KIT— 510(k) K874267
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K874267 for REVISED LABELING FOR PCP TEST KIT, Substantially Equivalent on 1987-11-13. 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
- Nutley, NJ, US
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More clearances from Roche Diagnostic Systems, Inc.
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