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510(k) K854946

TDXR 5-HIAA (URINE) by Abbott Laboratories — Product Code CDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device Class
Class I
Regulation Number
862.1390
Review Panel
CH
Submission Type

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