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510(k) K840758

IMMPULSE THEOPHYLLINE ASSAY REAGENTS by Paragon Diagnostics, Inc. — Product Code LER

K840758 is an FDA 510(k) premarket notification submitted by Paragon Diagnostics, Inc. for the device "IMMPULSE THEOPHYLLINE ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. 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 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
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)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (April 4, 1984)
  • K840853 — IMMPULSE TBC ASSAY REAGENTS (April 1, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)

Other clearances for product code LER

  • K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (July 13, 1994)
  • K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (December 26, 1990)
  • K882570 — TURBOX THEOPHYLLINE ASSAY (November 10, 1988)
  • K864409 — IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (December 22, 1986)
  • K863475 — THEOFAST(TM) TEST PACKAGE (November 5, 1986)
  • K842585 — THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (September 26, 1984)
  • K833070 — TDX THEOPHYLLINE (November 14, 1983)
  • K831514 — AMWA TDA THEOPHYLLINE TEST (June 30, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)
  • K820397 — AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (March 2, 1982)

FDA data resources