The following data is part of a De Novo classification by Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Fo with the FDA for Automated Blood Cell Separator -filtration.
DeNovo ID | DK781803 |
Device Name: | Automated Blood Cell Separator -Filtration |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | |
Contact | Device Classification Under Section 513(f)(2)(de N |
Product Code | GKT |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Hematology |
Classification Advisory | Hematology |
Type | 510(k) Traditional |
Date Received | 1978-12-08 |
Decision Date | 1979-01-17 |
Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |