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510(k) K841161

IMMPULSE AMIKACIN ASSAY REAGENTS by Paragon Diagnostics, Inc. — Product Code KLQ

K841161 is an FDA 510(k) premarket notification submitted by Paragon Diagnostics, Inc. for the device "IMMPULSE AMIKACIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. 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
Radioimmunoassay, Amikacin
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by Paragon Diagnostics, Inc.

  • K841162 — IMMPULSE GENTAMICIN 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 KLQ

  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K033884 — RANDOX AMIKACIN (June 9, 2004)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (June 25, 1985)
  • K843211 — AMIKACIN ANALYTICAL TEST PACK ACA (September 12, 1984)
  • K840193 — EMIT QST AMIKACIN ASSAY (March 23, 1984)
  • K832336 — STRATUS AMIKACIN FLUOROMETRIC (August 31, 1983)
  • K822657 — EMIT-AMD AMIKACIN ASSAY (September 28, 1982)

FDA data resources