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FDA 510(k)

RA-80 POSITIVE CONTROL

K-Number: K813309 · 1981-12-17

ApplicantSun-Kit
Decision Date1981-12-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RA-80 POSITIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Sun-Kit. It received FDA 510(k) clearance on 1981-12-17 under 510(k) number K813309. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RA-80 POSITIVE CONTROL?

RA-80 POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Sun-Kit. The 510(k) number is K813309.

When did RA-80 POSITIVE CONTROL receive FDA 510(k) clearance?

RA-80 POSITIVE CONTROL received FDA 510(k) clearance on 1981-12-17, under 510(k) number K813309.

Who is the listed applicant for RA-80 POSITIVE CONTROL?

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

What is the FDA product code for RA-80 POSITIVE CONTROL?

The FDA product code for RA-80 POSITIVE CONTROL is DHR.

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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.

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