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FDA 510(k)

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

K-Number: K090236 · 2009-04-27

ApplicantSiemens Healthcare Diagnostics
Decision Date2009-04-27
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-04-27 under 510(k) number K090236. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454?

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 is a medical device that received FDA 510(k) clearance on 2009-04-27. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K090236.

When did DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 receive FDA 510(k) clearance?

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 received FDA 510(k) clearance on 2009-04-27, under 510(k) number K090236.

Who is the listed applicant for DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454?

The FDA product code for DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 is LOJ.

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Related Devices (Code: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade Behring, Inc.K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYTosoh Medics, 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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