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FDA 510(k)

CAL/RAD UPGRADE MODEL 1030

K-Number: K880272 · 1988-02-29

ApplicantSun Nuclear Corp.
Decision Date1988-02-29
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAL/RAD UPGRADE MODEL 1030 is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corp.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K880272. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAL/RAD UPGRADE MODEL 1030?

CAL/RAD UPGRADE MODEL 1030 is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Sun Nuclear Corp.. The 510(k) number is K880272.

When did CAL/RAD UPGRADE MODEL 1030 receive FDA 510(k) clearance?

CAL/RAD UPGRADE MODEL 1030 received FDA 510(k) clearance on 1988-02-29, under 510(k) number K880272.

Who is the listed applicant for CAL/RAD UPGRADE MODEL 1030?

The FDA 510(k) record lists Sun Nuclear Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAL/RAD UPGRADE MODEL 1030?

The FDA product code for CAL/RAD UPGRADE MODEL 1030 is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Sun Nuclear Corp. as applicant

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K112981SUN 125C IONIZATION CHAMBERK1019923D SCANNER, MODEL 1230K092019MODEL 1014 PC ELECTROMETERK063021PROFILER 2K051921THE EDGE DETECTOR, MODEL 1118K013689RE-ENTRANT CHAMBER

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Related Devices (Code: KPT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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