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510(k) K941872

SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 by Helena Laboratories — Product Code GGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1994
Date Received
April 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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