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510(k) K900706

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA by Innotron of Oregon, Inc. — Product Code LGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1990
Date Received
February 12, 1990
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 of Oregon, Inc.

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  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (April 19, 1990)
  • K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (April 12, 1990)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)

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  • 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)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (May 28, 1987)
  • K870277 — MONITORX LASERX THEOPHYLLINE REAGENT SET (February 18, 1987)