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FDA 510(k)

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)

K-Number: K962836 · 1996-09-12

ApplicantHemagen Diagnostics, Inc.
Decision Date1996-09-12
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-09-12 under 510(k) number K962836. 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 HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)?

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K962836.

When did HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) receive FDA 510(k) clearance?

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) received FDA 510(k) clearance on 1996-09-12, under 510(k) number K962836.

Who is the listed applicant for HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)?

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

What is the FDA product code for HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)?

The FDA product code for HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) 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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