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FDA 510(k)

TINAQUANT RHEUMATOID FACTOR ASSAY

K-Number: K971379 · 1997-06-17

ApplicantBoehringer Mannheim Corp.
Decision Date1997-06-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINAQUANT RHEUMATOID FACTOR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K971379. 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 TINAQUANT RHEUMATOID FACTOR ASSAY?

TINAQUANT RHEUMATOID FACTOR ASSAY is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K971379.

When did TINAQUANT RHEUMATOID FACTOR ASSAY receive FDA 510(k) clearance?

TINAQUANT RHEUMATOID FACTOR ASSAY received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971379.

Who is the listed applicant for TINAQUANT RHEUMATOID FACTOR ASSAY?

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

What is the FDA product code for TINAQUANT RHEUMATOID FACTOR ASSAY?

The FDA product code for TINAQUANT RHEUMATOID FACTOR ASSAY is DHR.

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Other records listing Boehringer Mannheim 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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