Home / 510(k) Clearances / K852158

510(k) K852158

BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA by Bioprobe Intl., Inc. — Product Code LCQ

K852158 is an FDA 510(k) premarket notification submitted by Bioprobe Intl., Inc. for the device "BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
May 17, 1985
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

Other clearances for product code LCQ

  • K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (August 6, 1997)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (March 9, 1995)
  • 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)
  • K852013 — GENTAMICIN KIT(FPIA) (June 10, 1985)
  • K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (February 1, 1985)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)

FDA data resources