Digoxin & Phenytoin Control Sera

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K803097 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Amerlite Tsh Assay, LAN.0001/2001 240 & 144 Kit

  Class II

  FDA 510(k) K882907 Active Cleared 22 Sep 1988

• Amerlite Lh-30 Assay, LAN.0082/2082 240/144 Test

  Class I

  FDA 510(k) K880933 Active Cleared 28 Jul 1988

• Amerlite Fsh Assay, LAN.0077/2077 240 and 144 Test

  Class I

  FDA 510(k) K881142 Active Cleared 21 Jul 1988

• Amerlite Reproductive Endocrinology (Label Change)

  Class I

  FDA 510(k) K890708 Active Cleared 20 Mar 1989

• Prolactin Ria Kit

  Class I

  FDA 510(k) K800740 Active Cleared 16 Apr 1980

• Gold(Au 195) Gamma Camera Check(Flood)

  Class II

  FDA 510(k) K812236 Active Cleared 9 Sep 1981

See all devices from Amersham Corp. →