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510(k) K841706

INNOFLUOR PHENYTOIN by Innotron Diagnostics — Product Code LGR

K841706 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLUOR PHENYTOIN". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
April 23, 1984
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 Diagnostics

  • K850629 — INNOFLUOR THEOPHYLLINE (March 12, 1985)
  • K844721 — INNOFLUOR PRIMIDONE (January 8, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)
  • K841707 — INNOFLUOR PHENOBARBITAL (May 23, 1984)

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)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (August 21, 1987)

FDA data resources