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FDA 510(k)

IRMA TRUPOINT CREATININE CONTROL KIT

K-Number: K050983 · 2005-05-16

ApplicantInternational Technidyne Corporation
Decision Date2005-05-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA TRUPOINT CREATININE CONTROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corporation. It received FDA 510(k) clearance on 2005-05-16 under 510(k) number K050983. 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 IRMA TRUPOINT CREATININE CONTROL KIT?

IRMA TRUPOINT CREATININE CONTROL KIT is a medical device that received FDA 510(k) clearance on 2005-05-16. The listed applicant is International Technidyne Corporation. The 510(k) number is K050983.

When did IRMA TRUPOINT CREATININE CONTROL KIT receive FDA 510(k) clearance?

IRMA TRUPOINT CREATININE CONTROL KIT received FDA 510(k) clearance on 2005-05-16, under 510(k) number K050983.

Who is the listed applicant for IRMA TRUPOINT CREATININE CONTROL KIT?

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

What is the FDA product code for IRMA TRUPOINT CREATININE CONTROL KIT?

The FDA product code for IRMA TRUPOINT CREATININE CONTROL KIT is 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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