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FDA 510(k)

ELECSYS CA 15-3 CALCHECK

K-Number: K002353 · 2000-08-10

ApplicantRoche Diagnostics Corp.
Decision Date2000-08-10
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CA 15-3 CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K002353. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CA 15-3 CALCHECK?

ELECSYS CA 15-3 CALCHECK is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K002353.

When did ELECSYS CA 15-3 CALCHECK receive FDA 510(k) clearance?

ELECSYS CA 15-3 CALCHECK received FDA 510(k) clearance on 2000-08-10, under 510(k) number K002353.

Who is the listed applicant for ELECSYS CA 15-3 CALCHECK?

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

What is the FDA product code for ELECSYS CA 15-3 CALCHECK?

The FDA product code for ELECSYS CA 15-3 CALCHECK is JIS.

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Other records listing Roche Diagnostics Corp. 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.

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Related Devices (Code: JIS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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