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510(k) K830479

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE by Hoffmann-La Roche, Inc. — Product Code DKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)
  • K823572 — COBAS STANDARDS FOR CREATININE (January 7, 1983)

Other clearances for product code DKN

  • K914468 — ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (October 30, 1991)
  • K881816 — ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (July 28, 1988)
  • K812988 — AGGLUTEX BARBITURATES TEST KIT (December 31, 1981)