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510(k) K090846

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT by Perkinelmer, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2009
Date Received
March 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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