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510(k) K790380

LOW-TOX-H RABBIT COMPLEMENT by Cederlane Labs , Ltd. — Product Code KTQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 21, 1979
Date Received: February 27, 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