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FDA 510(k)

RF-LATEX SEIKEN REAGENT SYSTEM

K-Number: K960703 · 1996-04-19

ApplicantGlobe Management Support, Inc.
Decision Date1996-04-19
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RF-LATEX SEIKEN REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Globe Management Support, Inc.. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K960703. 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 RF-LATEX SEIKEN REAGENT SYSTEM?

RF-LATEX SEIKEN REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Globe Management Support, Inc.. The 510(k) number is K960703.

When did RF-LATEX SEIKEN REAGENT SYSTEM receive FDA 510(k) clearance?

RF-LATEX SEIKEN REAGENT SYSTEM received FDA 510(k) clearance on 1996-04-19, under 510(k) number K960703.

Who is the listed applicant for RF-LATEX SEIKEN REAGENT SYSTEM?

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

What is the FDA product code for RF-LATEX SEIKEN REAGENT SYSTEM?

The FDA product code for RF-LATEX SEIKEN REAGENT SYSTEM 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 Globe Management Support, 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.

K960702CRP-LATEX SEIKEN XR REAGENT SYSTEM

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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