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FDA 510(k)

RA SCREENING TEST

K-Number: K830611 · 1983-03-24

ApplicantTago, Inc.
Decision Date1983-03-24
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RA SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tago, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830611. 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 SCREENING TEST?

RA SCREENING TEST is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Tago, Inc.. The 510(k) number is K830611.

When did RA SCREENING TEST receive FDA 510(k) clearance?

RA SCREENING TEST received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830611.

Who is the listed applicant for RA SCREENING TEST?

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

What is the FDA product code for RA SCREENING TEST?

The FDA product code for RA SCREENING TEST is DHR.

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Other records listing Tago, 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.

K841734TAGO FIFFU-GEN, OROSOMUCOIDK841265TAGO DIFFU-GEN C-REACTIVE PROTEINK834218DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -K840404DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNOK833129TAGO DIFFU-GEN-APOLIPOPROTEIN B-100K830531MONO SCREENING TEST

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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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