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510(k) K002266

BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST by Branan Medical Corporation — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
July 25, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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  • K002268 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST (November 27, 2000)
  • K002264 — BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST (November 27, 2000)
  • K002342 — BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST (November 27, 2000)
  • K002417 — BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 1 (November 22, 2000)
  • K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AN (November 22, 2000)
  • K002587 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (November 22, 2000)
  • K002337 — BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (November 22, 2000)

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