FDA.report

510(k) K801233

Device
Celltrifuge Ii
Applicant
TRAVENOL LABORATORIES, S.A.
510(k) number
K801233
Product code
GKT
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-31
Date received
1980-05-27
Regulation
864.9245
Classification name
Separator, Automated, Blood Cell, Diagnostic
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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