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510(k) K850629

INNOFLUOR THEOPHYLLINE by Innotron Diagnostics — Product Code LGS

K850629 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLUOR THEOPHYLLINE". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
February 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

Other clearances by Innotron Diagnostics

  • K844721 — INNOFLUOR PRIMIDONE (January 8, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)
  • K841707 — INNOFLUOR PHENOBARBITAL (May 23, 1984)
  • K841706 — INNOFLUOR PHENYTOIN (May 22, 1984)

Other clearances for product code LGS

  • K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (June 8, 2007)
  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
  • K953016 — AXSYM THEOPHYLLINE II (August 24, 1995)
  • K951169 — CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (June 20, 1995)
  • K942991 — QMS THEOPHYLLINE CS (September 9, 1994)
  • K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (August 9, 1993)
  • K922991 — ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (August 27, 1992)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (May 28, 1987)

FDA data resources