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510(k) K972761

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY by Sealite Sciences, Inc. — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
July 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Growth Hormone
Device Class
Class I
Regulation Number
862.1370
Review Panel
CH
Submission Type

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