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FDA 510(k)

CARDIOIMMUNE XL CARDIAC MARKER CONTROL

K-Number: K061196 · 2006-05-30

ApplicantMicrogenics Corp.
Decision Date2006-05-30
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOIMMUNE XL CARDIAC MARKER CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2006-05-30 under 510(k) number K061196. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOIMMUNE XL CARDIAC MARKER CONTROL?

CARDIOIMMUNE XL CARDIAC MARKER CONTROL is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Microgenics Corp.. The 510(k) number is K061196.

When did CARDIOIMMUNE XL CARDIAC MARKER CONTROL receive FDA 510(k) clearance?

CARDIOIMMUNE XL CARDIAC MARKER CONTROL received FDA 510(k) clearance on 2006-05-30, under 510(k) number K061196.

Who is the listed applicant for CARDIOIMMUNE XL CARDIAC MARKER CONTROL?

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

What is the FDA product code for CARDIOIMMUNE XL CARDIAC MARKER CONTROL?

The FDA product code for CARDIOIMMUNE XL CARDIAC MARKER CONTROL is JJY.

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Related Devices (Code: JJY)

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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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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