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510(k) K830462

ABUSCREEN RADIOUMMUNOASSAY--URINE by Hoffmann-La Roche, Inc. — Product Code DOE

K830462 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "ABUSCREEN RADIOUMMUNOASSAY--URINE". The FDA issued a decision of Substantially Equivalent on March 24, 1983. 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. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 15, 1983
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 Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823580 — COBAS REAGENT FOR INORGANIC PHOSPHORUS (January 7, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)

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)
  • 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)

FDA data resources