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510(k) K002342

BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST by Branan Medical Corporation — Product Code JXM

K002342 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST". The FDA issued a decision of Substantially Equivalent on November 27, 2000. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Branan Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2000
Date Received
August 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

Other clearances by Branan Medical Corporation

  • K103227 — ORATECT ORAL FLUID DRUG SCREEN DEVICES (April 11, 2012)
  • K082508 — FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD (November 21, 2008)
  • 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)
  • K002265 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST (November 27, 2000)
  • K002587 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (November 22, 2000)
  • K002417 — BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 1 (November 22, 2000)
  • K002266 — BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST (November 22, 2000)
  • K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AN (November 22, 2000)
  • K002337 — BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (November 22, 2000)

Other clearances for product code JXM

  • K243498 — Alinity c Benzodiazepines Reagent Kit (December 11, 2024)
  • K221765 — ONLINE DAT Benzodiazepines II (December 23, 2022)
  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • K173963 — DRI Benzodiazepine Assay (February 21, 2018)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)
  • K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (August 2, 2017)
  • K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 23, 2016)
  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 13, 2015)

FDA data resources