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510(k) K813539

GENTAMICIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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Other clearances for product code LCQ

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  • K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (November 17, 1994)
  • K905721 — OPUS GENTAMICIN (February 21, 1991)
  • K904226 — 'TDXFLX ANALYZER (October 29, 1990)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (June 25, 1985)
  • K852013 — GENTAMICIN KIT(FPIA) (June 10, 1985)
  • K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (February 1, 1985)