Reference Assayed Chemistry Control Serum

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K874810 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Biotrol Bicarbonate (CO2) UV Hp)

  Class II

  FDA 510(k) K874941 Active Cleared 5 Jan 1988

• Biotrol Amylase CNPG3

  Class II

  FDA 510(k) K931141 Active Cleared 26 May 1993

• Biotrol Magnesium (Magon)

  Class I

  FDA 510(k) K921677 Active Cleared 26 May 1992

• Biotrol Alt/Tgp Monoreactif

  Class I

  FDA 510(k) K872830 Active Cleared 13 Aug 1987

• Biotrol Toxo Elisa Test M

  Class II

  FDA 510(k) K873293 Active Cleared 12 Apr 1988

• Biotrol Rub-E.I.a. Test G

  Class II

  FDA 510(k) K894544 Active Cleared 30 Aug 1989

See all devices from Biotrol, USA, Inc. →