Labcer Fibrinogen Assay Kit & Calibr.

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K812570 ↗

FDA Product Code

KQJ

Device Class

Class II

Regulation

21 CFR Part 864.7340

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Argyle Vac-U-Care 100cc Suct. Reservoir

  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

  Class I

  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Monoject(R) Trace Element Blood Collection Tube

  Class II

  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

  Class I

  FDA 510(k) K933510 Active Cleared 24 Feb 1994

• Kangaroo Feeding Tube Placment Stylet

  Class II

  FDA 510(k) K960632 Active Cleared 9 May 1996

See all devices from Sherwood Medical Co. →