PLASMACON N, PLASMACON L-1, PLASMACON L-2— 510(k) K062306
Substantially EquivalentR2 Diagnostics, Inc.
FDA 510(k) clearance K062306 for PLASMACON N, PLASMACON L-1, PLASMACON L-2, Substantially Equivalent on 2007-03-16. Applicant: R2 Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- R2 Diagnostics, Inc.
- Product code
- Code GGC
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
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