510(k) K791117

RABBIT COMPLEMENT by Calbiochem-Behring Corp. — Product Code KTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
June 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Complement
Device Class
Class I
Regulation Number
866.4100
Review Panel
IM
Submission Type