Fibrinogen High Abnormal Control - Level 3

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K946265 ↗

FDA Product Code

GIL

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Liquispex(Tm) Liquid B2M/Crp Control Level 1 and 2

  Class I

  FDA 510(k) K946049 Active Cleared 10 Feb 1995

• Liquispex Urine (Micro)Albumin Control

  Class I

  FDA 510(k) K962432 Active Cleared 5 Jul 1996

• Plasma Fibrinogen Control Level 1/Level 2

  Class II

  FDA 510(k) K935598 Active Cleared 2 May 1995

• Chemspex(Tm) Ammonia Control

  Class I

  FDA 510(k) K946143 Active Cleared 3 Feb 1995

• Liquispex Liquid B2M Control Level 1 And 2

  Class II

  FDA 510(k) K946048 Active Cleared 10 Feb 1995

• Whole Blood Glucose Control Level 1, 2, and 3/Whole Blood Glucose Linearity Control-LEVEL1, 2, 3, 4, 5, and 6

  Class I

  FDA 510(k) K964278 Active Cleared 22 Nov 1996

See all devices from Clinical Controls, Inc. →