Lyphochek Coagulation Control, Level 4, Model 743
FDA 510(k) K032611 · Bio-Rad
510(k) numberK032611
Submission
- Device name
- Lyphochek Coagulation Control, Level 4, Model 743
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- August 25, 2003
- Decision date
- September 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Lyphochek Coagulation Control, Level 4, Model 743 cleared by the FDA?
Lyphochek Coagulation Control, Level 4, Model 743 (K032611) received a 510(k) decision of Substantially Equivalent on September 17, 2003, 23 days after the submission was received.
What is the product code of K032611?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.