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510(k) K810871

LIGHTNING DIALYZER by Clintox Laboratories, Inc. — Product Code DHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
March 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ng4m(A), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5065
Review Panel
IM
Submission Type