Autopak 12 Digoxin Test Delivery System

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K791325 ↗

FDA Product Code

DPO

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Neonatal Ty Autopak Test Delivery System

  Class II

  FDA 510(k) K790665 Active Cleared 15 May 1979

• Micromedic Systems Isoflex

  Class I

  FDA 510(k) K820376 Active Cleared 16 Mar 1982

• Auto Pak Vitamin B-12

  Class II

  FDA 510(k) K790347 Active Cleared 27 Sep 1979

• Autopak Estriol Test Delivery System

  Class I

  FDA 510(k) K821678 Active Cleared 24 Jun 1982

• Micromedic Combostat Lh/Fsh Kit

  Class I

  FDA 510(k) K872309 Active Cleared 31 Jul 1987

• Microstat Gamma Counter

  Class I

  FDA 510(k) K842902 Active Cleared 9 Aug 1984

See all devices from Micromedic Systems →