FDA 510(k)

MODEL 4045 RADIONUCLIDE CALIBRATOR

K-Number: K828249 · 1982-09-29

Decision Date1982-09-29

Product Code

DecisionSubstantially Equivalent

Device Summary

MODEL 4045 RADIONUCLIDE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Radcal Corp.. It received FDA 510(k) clearance on 1982-09-29 under 510(k) number K828249. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4045 RADIONUCLIDE CALIBRATOR?

MODEL 4045 RADIONUCLIDE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-09-29. The listed applicant is Radcal Corp.. The 510(k) number is K828249.

When did MODEL 4045 RADIONUCLIDE CALIBRATOR receive FDA 510(k) clearance?

MODEL 4045 RADIONUCLIDE CALIBRATOR received FDA 510(k) clearance on 1982-09-29, under 510(k) number K828249.

Who is the listed applicant for MODEL 4045 RADIONUCLIDE CALIBRATOR?

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

Related Clinical Trials

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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Other records listing Radcal Corp. as applicant

K841785RADCAL MODEL 4046 RADIONUCLIDE CALIBR K841787RADCAL MODEL 4050 RADIONUCLIDE CALIB K841786RADCAL MODEL 4051 RADIONUCLIDE CALIBRA

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.