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FDA 510(k)

RADIONUCLIDE INFUSION SYSTEM

K-Number: K842568 · 1984-10-19

ApplicantSquibb Diagnostics
Decision Date1984-10-19
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RADIONUCLIDE INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Squibb Diagnostics. It received FDA 510(k) clearance on 1984-10-19 under 510(k) number K842568. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONUCLIDE INFUSION SYSTEM?

RADIONUCLIDE INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Squibb Diagnostics. The 510(k) number is K842568.

When did RADIONUCLIDE INFUSION SYSTEM receive FDA 510(k) clearance?

RADIONUCLIDE INFUSION SYSTEM received FDA 510(k) clearance on 1984-10-19, under 510(k) number K842568.

Who is the listed applicant for RADIONUCLIDE INFUSION SYSTEM?

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

What is the FDA product code for RADIONUCLIDE INFUSION SYSTEM?

The FDA product code for RADIONUCLIDE INFUSION SYSTEM is FRN.

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Other records listing Squibb Diagnostics as applicant

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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Related Devices (Code: FRN)

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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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