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FDA 510(k)

RA-CHECK

K-Number: K831467 · 1983-06-08

ApplicantDiagnostic Technology, Inc.
Decision Date1983-06-08
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RA-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831467. 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 RA-CHECK?

RA-CHECK is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K831467.

When did RA-CHECK receive FDA 510(k) clearance?

RA-CHECK received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831467.

Who is the listed applicant for RA-CHECK?

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

What is the FDA product code for RA-CHECK?

The FDA product code for RA-CHECK is DHR.

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Other records listing Diagnostic Technology, Inc. as applicant

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Related Devices (Code: DHR)

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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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