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510(k) K941737

SPECIALTY ASSAYED CONTROL-1 by Helena Laboratories — Product Code GIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089) (October 31, 1997)
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  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)