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FDA 510(k)

CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304

K-Number: K010417 · 2001-04-26

ApplicantNuclear Assoc., Div. Inovision LP
Decision Date2001-04-26
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Assoc., Div. Inovision LP. It received FDA 510(k) clearance on 2001-04-26 under 510(k) number K010417. 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 IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304?

CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Nuclear Assoc., Div. Inovision LP. The 510(k) number is K010417.

When did CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 receive FDA 510(k) clearance?

CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 received FDA 510(k) clearance on 2001-04-26, under 510(k) number K010417.

Who is the listed applicant for CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304?

The FDA 510(k) record lists Nuclear Assoc., Div. Inovision LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304?

The FDA product code for CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 is KPT. This falls under the In Vitro Diagnostics category.

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Official Source

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