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FDA 510(k)

RADIOISOTOPE CALIBRATOR MODEL 34-062

K-Number: K850815 · 1985-08-21

ApplicantVictoreen, Inc.
Decision Date1985-08-21
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOISOTOPE CALIBRATOR MODEL 34-062 is the device name listed in this FDA 510(k) record. The listed applicant is Victoreen, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K850815. 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 RADIOISOTOPE CALIBRATOR MODEL 34-062?

RADIOISOTOPE CALIBRATOR MODEL 34-062 is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Victoreen, Inc.. The 510(k) number is K850815.

When did RADIOISOTOPE CALIBRATOR MODEL 34-062 receive FDA 510(k) clearance?

RADIOISOTOPE CALIBRATOR MODEL 34-062 received FDA 510(k) clearance on 1985-08-21, under 510(k) number K850815.

Who is the listed applicant for RADIOISOTOPE CALIBRATOR MODEL 34-062?

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

What is the FDA product code for RADIOISOTOPE CALIBRATOR MODEL 34-062?

The FDA product code for RADIOISOTOPE CALIBRATOR MODEL 34-062 is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Victoreen, Inc. as applicant

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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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