Tray, Iced Injectable (26420)

FDA 510(k) K760066 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK760066

Submission

Device name
Tray, Iced Injectable (26420)
Applicant
Instrumentation Laboratory CO
Mchenry, IL, US
Received
June 16, 1976
Decision date
July 21, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXL – Injector, Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1660
Specialty
Cardiovascular

Other 510(k)s with product code DXL

510(k)DeviceApplicantDecision
K760500Tube, Heavy Glass Wall InjectionDXL · Traditional Unimetrics Corp.09/03/1976SE
K760448Syringe, CO2 Driven, Il Automatic InjectDXL · Traditional Instrumentation Laboratory CO08/27/1976SE

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Questions and answers

When was Tray, Iced Injectable (26420) cleared by the FDA?

Tray, Iced Injectable (26420) (K760066) received a 510(k) decision of Substantially Equivalent on July 21, 1976, 35 days after the submission was received.

What is the product code of K760066?

The FDA product code is DXL – Injector, Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.1660.