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FDA 510(k)

HOME HEALTH CHEKUP KIT

K-Number: K810488 · 1981-05-08

ApplicantHealthkit
Decision Date1981-05-08
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HOME HEALTH CHEKUP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Healthkit. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K810488. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME HEALTH CHEKUP KIT?

HOME HEALTH CHEKUP KIT is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Healthkit. The 510(k) number is K810488.

When did HOME HEALTH CHEKUP KIT receive FDA 510(k) clearance?

HOME HEALTH CHEKUP KIT received FDA 510(k) clearance on 1981-05-08, under 510(k) number K810488.

Who is the listed applicant for HOME HEALTH CHEKUP KIT?

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

What is the FDA product code for HOME HEALTH CHEKUP KIT?

The FDA product code for HOME HEALTH CHEKUP KIT is KHE.

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Related Devices (Code: KHE)

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

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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