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FDA 510(k)

RHEUMATOID FACTOR-RAPID CARD TEST #65114

K-Number: K830832 · 1983-04-18

ApplicantEmd Chemicals, Inc.
Decision Date1983-04-18
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR-RAPID CARD TEST #65114 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830832. 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 RHEUMATOID FACTOR-RAPID CARD TEST #65114?

RHEUMATOID FACTOR-RAPID CARD TEST #65114 is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830832.

When did RHEUMATOID FACTOR-RAPID CARD TEST #65114 receive FDA 510(k) clearance?

RHEUMATOID FACTOR-RAPID CARD TEST #65114 received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830832.

Who is the listed applicant for RHEUMATOID FACTOR-RAPID CARD TEST #65114?

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

What is the FDA product code for RHEUMATOID FACTOR-RAPID CARD TEST #65114?

The FDA product code for RHEUMATOID FACTOR-RAPID CARD TEST #65114 is DHR.

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Other records listing Emd Chemicals, 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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