510(k) K770866

RABBIT COMPLEMENT by Cedarlake Labs , Ltd. — Product Code DHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1977
Date Received
May 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protein, Complement, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.4100
Review Panel
IM
Submission Type