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FDA 510(k)

RHEUMOGEN TEST SYSTEM

K-Number: K790012 · 1979-01-26

ApplicantCalbiochem-Behring Corp.
Decision Date1979-01-26
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMOGEN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1979-01-26 under 510(k) number K790012. 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 RHEUMOGEN TEST SYSTEM?

RHEUMOGEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K790012.

When did RHEUMOGEN TEST SYSTEM receive FDA 510(k) clearance?

RHEUMOGEN TEST SYSTEM received FDA 510(k) clearance on 1979-01-26, under 510(k) number K790012.

Who is the listed applicant for RHEUMOGEN TEST SYSTEM?

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

What is the FDA product code for RHEUMOGEN TEST SYSTEM?

The FDA product code for RHEUMOGEN TEST SYSTEM is DHR.

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Other records listing Calbiochem-Behring Corp. 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.

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