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FDA 510(k)

ELECSYS CALCHECK CA 125II

K-Number: K981278 · 1998-04-23

ApplicantRoche Diagnostics GmbH
Decision Date1998-04-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK CA 125II 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 1998-04-23 under 510(k) number K981278. 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 CA 125II?

ELECSYS CALCHECK CA 125II is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Roche Diagnostics GmbH. The 510(k) number is K981278.

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

ELECSYS CALCHECK CA 125II received FDA 510(k) clearance on 1998-04-23, under 510(k) number K981278.

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

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 CA 125II?

The FDA product code for ELECSYS CALCHECK CA 125II 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.

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Related Devices (Code: JJX)

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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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