Monoject Sample Capillary Plasma Sep W/Lith Hepar

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K853152 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

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  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Labcer Fibrinogen Assay Kit & Calibr.

  Class II

  FDA 510(k) K812570 Active Cleared 2 Oct 1981

• 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

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  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →

• What is the Monoject Sample Capillary Plasma Sep w/Lith Hepar used for?

  It is designed for the separation of plasma from capillary blood samples using lithium heparin as an anticoagulant, intended for use in clinical laboratory settings.

• How is the Monoject Sample Capillary Plasma Sep w/Lith Hepar supplied and is it reusable?

  It is supplied as a sterile, single-use device, meaning it is intended for one-time use only and should not be reprocessed or reused to maintain sterility and performance.

• What regulatory clearance does the Monoject Sample Capillary Plasma Sep w/Lith Hepar have?

  The device received FDA 510(k) clearance under number K853152 on August 23, 1985, and is classified as a Class II device under product code JKA.