LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783— 510(k) K012722
Substantially EquivalentBio-Rad
FDA 510(k) clearance K012722 for LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783, Substantially Equivalent on 2001-09-18. Applicant: Bio-Rad. Device class: 2.
Clearance details
- Applicant
- Bio-Rad
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code GGN
view all- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K161316 — George King Coumadin Plasma
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
More clearances from Bio-Rad
view allData sourced from openFDA. This site is unofficial and independent of the FDA.