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Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip - Monojec

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243660

by Cardinalhealth

Identifiers

510(k) Number
K243660 FDA 510(k)
FDA Product Code
FMF FDA 510(k)
Models / Variants
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) FDA 510(k)
Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777) FDA 510(k)
Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777) FDA 510(k)
Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777) FDA 510(k)
Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777) FDA 510(k)
Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777) FDA 510(k)
Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777) FDA 510(k)
Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934) FDA 510(k)
Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937) FDA 510(k)
Monojec FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip - Monojec by Cardinalhealth — Class II — FDA_510K — listed in FDA 510(k) — 10 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA 510(k) K243660 24 fields · synced Jun 19, 2026