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FDA 510(k)

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

K-Number: K991467 · 1999-06-10

ApplicantKamiya Biomedical Co.
Decision Date1999-06-10
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1999-06-10 under 510(k) number K991467. 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 K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET?

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1999-06-10. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K991467.

When did K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET receive FDA 510(k) clearance?

K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET received FDA 510(k) clearance on 1999-06-10, under 510(k) number K991467.

Who is the listed applicant for K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET?

The FDA product code for K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET is DHR.

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Other records listing Kamiya Biomedical Co. 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.

K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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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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