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FDA 510(k)

OLYMPUS AFP - ALPHA-FETOPROTEIN

K-Number: K081709 · 2009-03-16

ApplicantOlympus Life Science Research Europa GmbH (Europa)
Decision Date2009-03-16
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS AFP - ALPHA-FETOPROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Life Science Research Europa GmbH (Europa). It received FDA 510(k) clearance on 2009-03-16 under 510(k) number K081709. 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 OLYMPUS AFP - ALPHA-FETOPROTEIN?

OLYMPUS AFP - ALPHA-FETOPROTEIN is a medical device that received FDA 510(k) clearance on 2009-03-16. The listed applicant is Olympus Life Science Research Europa GmbH (Europa). The 510(k) number is K081709.

When did OLYMPUS AFP - ALPHA-FETOPROTEIN receive FDA 510(k) clearance?

OLYMPUS AFP - ALPHA-FETOPROTEIN received FDA 510(k) clearance on 2009-03-16, under 510(k) number K081709.

Who is the listed applicant for OLYMPUS AFP - ALPHA-FETOPROTEIN?

The FDA 510(k) record lists Olympus Life Science Research Europa GmbH (Europa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS AFP - ALPHA-FETOPROTEIN?

The FDA product code for OLYMPUS AFP - ALPHA-FETOPROTEIN is LOJ.

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Other records listing Olympus Life Science Research Europa GmbH (Europa) 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.

K080435OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181K080094OLYMPUS TOTAL BHCG TEST SYSTEN

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 DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK080017VIDAS 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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