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510(k) K002417

BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D by Branan Medical Corporation — Product Code DJR

K002417 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Branan Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
August 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
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)
  • K002342 — BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST (November 27, 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)
  • K002587 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (November 22, 2000)

Other clearances for product code DJR

  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K182779 — ARK EDDP Assay (November 21, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (October 5, 2015)
  • K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib (July 24, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (May 31, 2013)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)

FDA data resources