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510(k) K933572

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) by Immunalysis Corporation — Product Code DOE

K933572 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)". The FDA issued a decision of Substantially Equivalent on April 6, 1994. 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. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1994
Date Received
July 23, 1993
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

  • K010079 — INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (May 29, 2001)
  • K010080 — INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (May 29, 2001)
  • K011011 — LIVESURE MORPHINE SCREEN TEST (April 13, 2001)
  • K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AN (November 22, 2000)
  • 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)
  • 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