FDA PMA FDA Unclassified Approved 🇺🇸 United States

Separator, Automated, Blood Cell And Plasma, Therapeutic

PMA: P820002 · Decision Jan 31, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19

Basic Information

Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Trade Name
CRYOMAX(TM)
PMA Number
P820002
Device Class
FDA Unclassified
Product Code
LKN
Generic Name
Separator, automated, blood cell and plasma, therapeutic
Medical Specialty
Unknown
Advisory Committee
Gastroenterology, Urology
Decision
Approved
Decision Code
APPR
Decision Date
January 31, 1983
Date Received
January 5, 1982
Expedited Review
N
Docket Number
83M-0039

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic