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FDA 510(k)

LEAP RHEUMATOID FACTOR TEST KIT

K-Number: K831941 · 1983-07-18

ApplicantCooper Diagnostics, Inc.
Decision Date1983-07-18
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LEAP RHEUMATOID FACTOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831941. 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 LEAP RHEUMATOID FACTOR TEST KIT?

LEAP RHEUMATOID FACTOR TEST KIT is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Cooper Diagnostics, Inc.. The 510(k) number is K831941.

When did LEAP RHEUMATOID FACTOR TEST KIT receive FDA 510(k) clearance?

LEAP RHEUMATOID FACTOR TEST KIT received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831941.

Who is the listed applicant for LEAP RHEUMATOID FACTOR TEST KIT?

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

What is the FDA product code for LEAP RHEUMATOID FACTOR TEST KIT?

The FDA product code for LEAP RHEUMATOID FACTOR TEST KIT is DHR.

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Related Devices (Code: DHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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