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510(k) K895827

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET by Innotron of Oregon, Inc. — Product Code LGR

K895827 is an FDA 510(k) premarket notification submitted by Innotron of Oregon, Inc. for the device "INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Innotron of Oregon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
October 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

Other clearances by Innotron of Oregon, Inc.

  • K903101 — INNOFLUOR (TM) AMIKACIN CALIBRATOR SET (August 22, 1990)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (April 19, 1990)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (April 12, 1990)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)

Other clearances for product code LGR

  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)
  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K953840 — AXSYM PHENYTOIN II (September 25, 1995)
  • K946328 — TDX(R)/TDXFLX(R) PHENYTOIN II (March 28, 1995)
  • K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (October 27, 1994)
  • K935375 — AXSYM PHENYTOIN ASSAY (June 21, 1994)
  • K936131 — COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (March 11, 1994)
  • K896868 — OPUS PHENYTOIN TEST SYSTEM (January 2, 1990)
  • K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (August 21, 1987)
  • K862554 — IMMPULSE PHENYTOIN ASSAY REAGENT (July 16, 1986)

FDA data resources