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FDA 510(k)

CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165

K-Number: K030066 · 2003-08-29

ApplicantNuclear Associates
Decision Date2003-08-29
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Associates. It received FDA 510(k) clearance on 2003-08-29 under 510(k) number K030066. 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 MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165?

CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 is a medical device that received FDA 510(k) clearance on 2003-08-29. The listed applicant is Nuclear Associates. The 510(k) number is K030066.

When did CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 receive FDA 510(k) clearance?

CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 received FDA 510(k) clearance on 2003-08-29, under 510(k) number K030066.

Who is the listed applicant for CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165?

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

What is the FDA product code for CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165?

The FDA product code for CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 is KPT. This falls under the In Vitro Diagnostics category.

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Related Devices (Code: KPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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