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510(k) K852317

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR by Roche Diagnostic Systems, Inc. — Product Code KLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Amikacin
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by Roche Diagnostic Systems, Inc.

  • K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (May 3, 1999)
  • K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (February 11, 1999)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

Other clearances for product code KLQ

  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K033884 — RANDOX AMIKACIN (June 9, 2004)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K843211 — AMIKACIN ANALYTICAL TEST PACK ACA (September 12, 1984)
  • K841161 — IMMPULSE AMIKACIN ASSAY REAGENTS (May 2, 1984)
  • K840193 — EMIT QST AMIKACIN ASSAY (March 23, 1984)
  • K832336 — STRATUS AMIKACIN FLUOROMETRIC (August 31, 1983)
  • K822657 — EMIT-AMD AMIKACIN ASSAY (September 28, 1982)