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FDA 510(k)

ELECSYS CALCHECK FERRITIN

K-Number: K981281 · 1998-04-24

ApplicantRoche Diagnostics GmbH
Decision Date1998-04-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK FERRITIN 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 1998-04-24 under 510(k) number K981281. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CALCHECK FERRITIN?

ELECSYS CALCHECK FERRITIN is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Roche Diagnostics GmbH. The 510(k) number is K981281.

When did ELECSYS CALCHECK FERRITIN receive FDA 510(k) clearance?

ELECSYS CALCHECK FERRITIN received FDA 510(k) clearance on 1998-04-24, under 510(k) number K981281.

Who is the listed applicant for ELECSYS CALCHECK FERRITIN?

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 CALCHECK FERRITIN?

The FDA product code for ELECSYS CALCHECK FERRITIN is JJX.

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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 CalcitoninK981282ELECSYS AFPK981278ELECSYS CALCHECK CA 125II

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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