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510(k) K961984

PORPHOBILINOGEN (PBG) by Trace America, Inc. — Product Code JNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
May 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
Device Class
Class I
Regulation Number
862.1590
Review Panel
CH
Submission Type

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