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510(k) K813541

AMIKACIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code KLQ

K813541 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "AMIKACIN FLUORESCENT IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1982
Date Received
December 21, 1981
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 American Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (May 15, 2006)
  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)

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

FDA data resources