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FDA 510(k)

RAICHEM RHEUMATOID FACTOR SPIA

K-Number: K970373 · 1997-04-17

ApplicantHenage Diagnostics, Inc.
Decision Date1997-04-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAICHEM RHEUMATOID FACTOR SPIA is the device name listed in this FDA 510(k) record. The listed applicant is Henage Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K970373. 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 RAICHEM RHEUMATOID FACTOR SPIA?

RAICHEM RHEUMATOID FACTOR SPIA is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Henage Diagnostics, Inc.. The 510(k) number is K970373.

When did RAICHEM RHEUMATOID FACTOR SPIA receive FDA 510(k) clearance?

RAICHEM RHEUMATOID FACTOR SPIA received FDA 510(k) clearance on 1997-04-17, under 510(k) number K970373.

Who is the listed applicant for RAICHEM RHEUMATOID FACTOR SPIA?

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

What is the FDA product code for RAICHEM RHEUMATOID FACTOR SPIA?

The FDA product code for RAICHEM RHEUMATOID FACTOR SPIA is 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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