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510(k) K841162

IMMPULSE GENTAMICIN ASSAY REAGENTS by Paragon Diagnostics, Inc. — Product Code LCQ

K841162 is an FDA 510(k) premarket notification submitted by Paragon Diagnostics, Inc. for the device "IMMPULSE GENTAMICIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Paragon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
March 19, 1984
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 Paragon Diagnostics, Inc.

  • K841161 — IMMPULSE AMIKACIN ASSAY REAGENTS (May 2, 1984)
  • K840852 — IMMPULSE T4 ASSAY REAGENTS (April 18, 1984)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (April 4, 1984)
  • K840758 — IMMPULSE THEOPHYLLINE ASSAY REAGENTS (April 4, 1984)
  • K840853 — IMMPULSE TBC ASSAY REAGENTS (April 1, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)

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