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FDA 510(k)

SERATEST RF (HEMAGGLUTINATION) KIT

K-Number: K855221 · 1986-04-22

ApplicantHemagen Diagnostics, Inc.
Decision Date1986-04-22
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERATEST RF (HEMAGGLUTINATION) KIT 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 1986-04-22 under 510(k) number K855221. 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 SERATEST RF (HEMAGGLUTINATION) KIT?

SERATEST RF (HEMAGGLUTINATION) KIT is a medical device that received FDA 510(k) clearance on 1986-04-22. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K855221.

When did SERATEST RF (HEMAGGLUTINATION) KIT receive FDA 510(k) clearance?

SERATEST RF (HEMAGGLUTINATION) KIT received FDA 510(k) clearance on 1986-04-22, under 510(k) number K855221.

Who is the listed applicant for SERATEST RF (HEMAGGLUTINATION) KIT?

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 SERATEST RF (HEMAGGLUTINATION) KIT?

The FDA product code for SERATEST RF (HEMAGGLUTINATION) KIT is DHR.

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Other records listing Hemagen Diagnostics, Inc. as applicant

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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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

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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