Thrombo Tek Pse, Model 90-480
FDA 510(k) K082631 · R2 Diagnostics, Inc.
510(k) numberK082631
Submission
- Device name
- Thrombo Tek Pse, Model 90-480
- Applicant
- R2 Diagnostics, Inc.
South Bend, IN, US - Received
- September 10, 2008
- Decision date
- December 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Thrombo Tek Pse, Model 90-480 cleared by the FDA?
Thrombo Tek Pse, Model 90-480 (K082631) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 98 days after the submission was received.
What is the product code of K082631?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.