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FDA 510(k)

ELECSYS CA 125 II CALSET

K-Number: K003969 · 2001-01-12

ApplicantRoche Diagnostics Corp.
Decision Date2001-01-12
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CA 125 II CALSET 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 2001-01-12 under 510(k) number K003969. 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 125 II CALSET?

ELECSYS CA 125 II CALSET is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K003969.

When did ELECSYS CA 125 II CALSET receive FDA 510(k) clearance?

ELECSYS CA 125 II CALSET received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003969.

Who is the listed applicant for ELECSYS CA 125 II CALSET?

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 125 II CALSET?

The FDA product code for ELECSYS CA 125 II CALSET 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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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