Monoject Sterile 1/2 Cc & 1cc Syringes W & W/O Nee

• • Ongoing Z-1768-2026 FDA Class II ·initiated 27 Feb 2026

  The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

510(k) Number

K851090 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Labcer Fibrinogen Assay Kit & Calibr.

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• Monoject(R) Trace Element Blood Collection Tube

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• Monoject Samplette Amber Capillary Serum Separator

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• Argyle Turkel Safety Trocar Thoracic Catheter

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See all devices from Sherwood Medical Co. →