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FDA 510(k)

ENCORE RHEUMATOID FACTOR EIA

K-Number: K924056 · 1992-09-25

ApplicantClark Laboratories, Inc.
Decision Date1992-09-25
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENCORE RHEUMATOID FACTOR EIA is the device name listed in this FDA 510(k) record. The listed applicant is Clark Laboratories, Inc.. It received FDA 510(k) clearance on 1992-09-25 under 510(k) number K924056. 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 ENCORE RHEUMATOID FACTOR EIA?

ENCORE RHEUMATOID FACTOR EIA is a medical device that received FDA 510(k) clearance on 1992-09-25. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K924056.

When did ENCORE RHEUMATOID FACTOR EIA receive FDA 510(k) clearance?

ENCORE RHEUMATOID FACTOR EIA received FDA 510(k) clearance on 1992-09-25, under 510(k) number K924056.

Who is the listed applicant for ENCORE RHEUMATOID FACTOR EIA?

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

What is the FDA product code for ENCORE RHEUMATOID FACTOR EIA?

The FDA product code for ENCORE RHEUMATOID FACTOR EIA is DHR.

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Other records listing Clark Laboratories, Inc. as applicant

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.

K980596VCA IGM ELISA TEST SYSTEMK980912VCA IGG ELISA TEST SYSTEMK980598EBNA-1 IGM ELISA TEST SYSTEMK973123EA-D IGG ELISA TEST SYSTEMK931543ENCORE ENA COMBINED EIAK925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

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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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