510(k) K900105

COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC by Cobe Laboratories, Inc. — Product Code LKN

K900105 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC". The FDA issued a decision of Substantially Equivalent on Mar 22, 1991. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Cobe Laboratories, Inc. has 76 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 22, 1991
Date Received
Jan 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class
Class U
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K900105. Report a data issue: hello@regdatalab.com.