Factor Deficient Substrate Plasma Ii

510(k) Number

K840927 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Heparin Coagulation Control Plasma 1-

  Class II

  FDA 510(k) K841462 Active Cleared 1 Jun 1984

• Dia Reptin

  Class I

  FDA 510(k) K841365 Active Cleared 1 Jun 1984

• Calcium Chloride

  Class II

  FDA 510(k) K841522 Active Cleared 30 Apr 1984

• Fibrinogen Test

  Class II

  FDA 510(k) K834571 Active Cleared 4 Feb 1984

• Diatimer-1 Blood Plasma Clot Timing Instrument

  Class II

  FDA 510(k) K854089 Active Cleared 6 Jan 1986

• Diacelin

  Class II

  FDA 510(k) K840288 Active Cleared 23 Apr 1984

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