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510(k) K843211

AMIKACIN ANALYTICAL TEST PACK ACA by E.I. Dupont DE Nemours & Co., Inc. — Product Code KLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
August 15, 1984
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

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Other clearances for product code KLQ

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  • 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)
  • K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (June 25, 1985)
  • 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)