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510(k) K971534

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL by Beckman — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1997
Date Received
April 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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  • K893583 — BECKMAN CHOLINESTERASE REAGENT KIT (August 15, 1989)

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