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510(k) K002587

BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST by Branan Medical Corporation — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
August 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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  • K002337 — BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (November 22, 2000)
  • K002266 — BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST (November 22, 2000)

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