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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

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

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Other clearances for product code DOE

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  • 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)