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510(k) K812988

AGGLUTEX BARBITURATES TEST KIT by Hoffmann-La Roche, Inc. — Product Code DKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
October 26, 1981
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.

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  • K831694 — RENAK (July 19, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (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)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)