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510(k) K970093

TYROSINE 50-HOUR REAGENT KIT by Astoria-Pacific, Inc. — Product Code CDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1998
Date Received
January 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine
Device Class
Class I
Regulation Number
862.1730
Review Panel
CH
Submission Type

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