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510(k) K002418

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D by Branan Medical Corporation — Product Code DOE

K002418 is an FDA 510(k) premarket notification submitted by Branan Medical Corporation for the device "BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3640. 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
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Device Class
Class II
Regulation Number
862.3640
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)
  • 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)
  • 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 DOE

  • K010080 — INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (May 29, 2001)
  • K010079 — INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (May 29, 2001)
  • K011011 — LIVESURE MORPHINE SCREEN TEST (April 13, 2001)
  • K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 (June 1, 1995)
  • K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (August 9, 1994)
  • K933572 — URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (April 6, 1994)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)
  • K863913 — THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT (March 19, 1987)
  • K864168 — MORPHINE ROCHE (R) EIA TEST (March 16, 1987)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)

FDA data resources