Lyphochek Hemostasis, Models 798, 799
FDA 510(k) K020878 · Bio-Rad
510(k) numberK020878
Submission
- Device name
- Lyphochek Hemostasis, Models 798, 799
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- March 18, 2002
- Decision date
- April 15, 2002
- 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 Lyphochek Hemostasis, Models 798, 799 cleared by the FDA?
Lyphochek Hemostasis, Models 798, 799 (K020878) received a 510(k) decision of Substantially Equivalent on April 15, 2002, 28 days after the submission was received.
What is the product code of K020878?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.