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510(k) K841707

INNOFLUOR PHENOBARBITAL by Innotron Diagnostics — Product Code LGQ

K841707 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLUOR PHENOBARBITAL". The FDA issued a decision of Substantially Equivalent on May 23, 1984. The device falls under product code LGQ (Fluorescence Polarization Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
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)
  • K841706 — INNOFLUOR PHENYTOIN (May 22, 1984)

Other clearances for product code LGQ

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 1997)
  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K940596 — AXSYM PHENOBARBITAL (June 21, 1994)
  • K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (March 11, 1994)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K894525 — FPR PHENOBARBITAL KIT (August 28, 1989)
  • K872397 — COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (July 21, 1987)
  • K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (November 10, 1986)
  • K862528 — IMMPULSE PHENOBARBITAL ASSAY REAGENTS (July 16, 1986)
  • K854044 — TDX BARBITURATES (October 28, 1985)

FDA data resources