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510(k) K782025

GENTAMICIN FLUROIMMUNASSAY KIT by Technia Diagnostics , Ltd. — Product Code LCQ

K782025 is an FDA 510(k) premarket notification submitted by Technia Diagnostics , Ltd. for the device "GENTAMICIN FLUROIMMUNASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Technia Diagnostics , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 5, 1978
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 by Technia Diagnostics , Ltd.

  • K861978 — AUTOFLUOR V (June 10, 1986)
  • K801843 — T3(125) RADIOIMMUNOASSAY KIT (September 16, 1980)
  • K801202 — DIGOXIN RADIOIMMUNOASSAY KIT (June 20, 1980)
  • K801203 — CORTISOL RADIOIMMUNOASSAY KIT (June 9, 1980)
  • K791361 — T3 UPTAKE RADIOIMMUNOASSAY KIT (August 16, 1979)
  • K790919 — HPL RIA KIT (June 28, 1979)
  • K790495 — THYROXINE RIA KIT (May 3, 1979)
  • K782024 — RIA KIT, VITAMIN B12 (February 28, 1979)

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)
  • 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)

FDA data resources