Innotron Innofluor Pheytoin Reagent Set

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K872563 ↗

FDA Product Code

LGR

Device Class

Class II

Regulation

21 CFR Part 862.3350

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Innofluor Phenytoin Calibrator Set

  Class II

  FDA 510(k) K872142 Active Cleared 21 Jul 1987

• Colorimeters Series One 12

  Class I

  FDA 510(k) K830101 Active Cleared 28 Jan 1983

• Innofluor Vancomycin Calibrator Set

  Class II

  FDA 510(k) K872644 Active Cleared 21 Jul 1987

• Hydragamma 16

  Class I

  FDA 510(k) K800601 Active Cleared 10 Apr 1980

• Innofluor(Tm) Gentamicin Calibrator Set

  Class II

  FDA 510(k) K872462 Active Cleared 21 Jul 1987

• Innofluor(Tm) Phenobarbital Calibrator Set

  Class II

  FDA 510(k) K872461 Active Cleared 21 Jul 1987

See all devices from Innotron of Oregon, Inc. →