Plasmacon N, Plasmacon L-1, Plasmacon L-2
FDA 510(k) K062306 · R2 Diagnostics, Inc.
510(k) numberK062306
Submission
- Device name
- Plasmacon N, Plasmacon L-1, Plasmacon L-2
- Applicant
- R2 Diagnostics, Inc.
South Bend, IN, US - Received
- August 8, 2006
- Decision date
- March 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Plasmacon N, Plasmacon L-1, Plasmacon L-2 cleared by the FDA?
Plasmacon N, Plasmacon L-1, Plasmacon L-2 (K062306) received a 510(k) decision of Substantially Equivalent on March 16, 2007, 220 days after the submission was received.
What is the product code of K062306?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.