J.T. Baker Immunoglobulin G Nephelometri

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K801281 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Amp Buffer

  Class II

  FDA 510(k) K760410 Active Cleared 29 Oct 1976

• Dynazyme Tm II Cardiak-Mb

  Class II

  FDA 510(k) K772172 Active Cleared 6 Dec 1977

• J.T. Baker Alpha-1-Antitrypsin Nephelo

  Class II

  FDA 510(k) K801669 Active Cleared 16 Sep 1980

• Dynazyme II Alkaline Phosphatase

  Class II

  FDA 510(k) K771085 Active Cleared 4 Aug 1977

• Azide Free Blood Diluting Reagent

  Class I

  FDA 510(k) K771787 Active Cleared 7 Oct 1977

• Diag. Conducta Rate Bun Reag. Set

  Class II

  FDA 510(k) K771060 Active Cleared 21 Jul 1977

See all devices from J.T. Baker Chemical Co. →