Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon la
FDA 510(k) K083878 · R2 Diagnostics, Inc.
510(k) numberK083878
Submission
- Device name
- Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon la
- Applicant
- R2 Diagnostics, Inc.
South Bend, IN, US - Received
- December 29, 2008
- Decision date
- June 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIR – Reagent, Russel Viper Venom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8950
- Specialty
- Hematology
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| K990302 | Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional | Instrumentation Laboratory CO | 04/08/1999SE |
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Questions and answers
When was Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon la cleared by the FDA?
Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon la (K083878) received a 510(k) decision of Substantially Equivalent on June 25, 2010, 543 days after the submission was received.
What is the product code of K083878?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.