Specimen Collection & Transport System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844475 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Screening Device

  Class I

  FDA 510(k) K882101 Active Cleared 1 Jul 1988

• Cell Counting Grid Graticule

  Class I

  FDA 510(k) K874190 Active Cleared 5 Jan 1988

• Portable Diagnostic Laboratory

  Class I

  FDA 510(k) K844476 Active Cleared 13 Mar 1985

• Hand-Held Slide Reader

  Class I

  FDA 510(k) K844473 Active Cleared 4 Jan 1985

• Mcarthur Microscope Plastic Version with Acc.

  Class I

  FDA 510(k) K854735 Active Cleared 10 Dec 1985

• Mcarthur Microscope, Standard Metal Version

  Class I

  FDA 510(k) K864049 Active Cleared 29 Oct 1986

See all devices from Portable Medical Laboratories, Inc. →