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FDA 510(k)

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET

K-Number: K964418 · 1996-12-13

ApplicantKamiya Technology Services
Decision Date1996-12-13
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Technology Services. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K964418. 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 N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET?

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Kamiya Technology Services. The 510(k) number is K964418.

When did N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET receive FDA 510(k) clearance?

N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET received FDA 510(k) clearance on 1996-12-13, under 510(k) number K964418.

Who is the listed applicant for N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET?

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

What is the FDA product code for N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET?

The FDA product code for N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET is DHR.

Related Clinical Trials

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.

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Other records listing Kamiya Technology Services 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.

K964415N-ASSAY TIA RHEUMATOID FACTOR TEST KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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