FDA 510(k)

RHEUMAGEN RF T-CONTROL

K-Number: K904310 · 1991-05-31

Decision Date1991-05-31

Product CodeDHR

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

RHEUMAGEN RF T-CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1991-05-31 under 510(k) number K904310. 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 RHEUMAGEN RF T-CONTROL?

RHEUMAGEN RF T-CONTROL is a medical device that received FDA 510(k) clearance on 1991-05-31. The listed applicant is Biokit USA, Inc.. The 510(k) number is K904310.

When did RHEUMAGEN RF T-CONTROL receive FDA 510(k) clearance?

RHEUMAGEN RF T-CONTROL received FDA 510(k) clearance on 1991-05-31, under 510(k) number K904310.

Who is the listed applicant for RHEUMAGEN RF T-CONTROL?

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

What is the FDA product code for RHEUMAGEN RF T-CONTROL?

The FDA product code for RHEUMAGEN RF T-CONTROL is DHR.

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Other records listing Biokit USA, Inc. as applicant

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Related Devices (Code: DHR)

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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.