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510(k) K100101

GSP NEONATALGALT KIT, MODEL 3303-001U by Perkinelmer, Inc. — Product Code KQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Device Class
Class II
Regulation Number
862.1315
Review Panel
CH
Submission Type

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Other clearances for product code KQP

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  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)
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