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FDA 510(k)

ELECSYS AFP

K-Number: K981282 · 1998-05-01

ApplicantRoche Diagnostics GmbH
Decision Date1998-05-01
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS AFP is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics GmbH. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K981282. 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 ELECSYS AFP?

ELECSYS AFP is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Roche Diagnostics GmbH. The 510(k) number is K981282.

When did ELECSYS AFP receive FDA 510(k) clearance?

ELECSYS AFP received FDA 510(k) clearance on 1998-05-01, under 510(k) number K981282.

Who is the listed applicant for ELECSYS AFP?

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

What is the FDA product code for ELECSYS AFP?

The FDA product code for ELECSYS AFP is LOJ.

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Other records listing Roche Diagnostics GmbH 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.

K252431Elecsys CalcitoninK981281ELECSYS CALCHECK FERRITINK981278ELECSYS CALCHECK CA 125II

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 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.

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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