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510(k) K970701

DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) by Diagnostic Systems Laboratories, Inc. — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
February 26, 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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