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510(k) K840847

IMMPULSE TOBRAMYCIN ASSAY REAGENTS by Paragon Diagnostics, Inc. — Product Code LCR

K840847 is an FDA 510(k) premarket notification submitted by Paragon Diagnostics, Inc. for the device "IMMPULSE TOBRAMYCIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Paragon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

Other clearances by Paragon Diagnostics, Inc.

  • K841161 — IMMPULSE AMIKACIN ASSAY REAGENTS (May 2, 1984)
  • K841162 — IMMPULSE GENTAMICIN ASSAY REAGENTS (May 2, 1984)
  • K840852 — IMMPULSE T4 ASSAY REAGENTS (April 18, 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 LCR

  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE (September 13, 1996)
  • K952568 — BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (August 8, 1995)
  • K911940 — OPUS(R) TOBRAMYCIN (July 1, 1991)
  • K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (June 28, 1991)
  • K854873 — INTRAOCULAR PRESSURE REDUCER (February 4, 1986)
  • K850058 — DU PONT TOBRAMYCIN ASSAY REAGENTS (January 18, 1985)
  • K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (August 26, 1983)
  • K822197 — NEEDLE HOLDERS (August 16, 1982)

FDA data resources