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FDA 510(k)

CRP-LATEX SEIKEN XR REAGENT SYSTEM

K-Number: K960702 · 1996-04-19

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

Device Summary

CRP-LATEX SEIKEN XR 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 K960702. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRP-LATEX SEIKEN XR REAGENT SYSTEM?

CRP-LATEX SEIKEN XR 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 K960702.

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

CRP-LATEX SEIKEN XR REAGENT SYSTEM received FDA 510(k) clearance on 1996-04-19, under 510(k) number K960702.

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

The FDA product code for CRP-LATEX SEIKEN XR REAGENT SYSTEM is DCK.

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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.

K960703RF-LATEX SEIKEN REAGENT SYSTEM

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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