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FDA 510(k)

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

K-Number: K050975 · 2006-03-02

ApplicantNano-Ditech Co.
Decision Date2006-03-02
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Nano-Ditech Co.. It received FDA 510(k) clearance on 2006-03-02 under 510(k) number K050975. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN?

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN is a medical device that received FDA 510(k) clearance on 2006-03-02. The listed applicant is Nano-Ditech Co.. The 510(k) number is K050975.

When did NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN receive FDA 510(k) clearance?

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN received FDA 510(k) clearance on 2006-03-02, under 510(k) number K050975.

Who is the listed applicant for NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN?

The FDA 510(k) record lists Nano-Ditech Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN?

The FDA product code for NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN is MMI.

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Other records listing Nano-Ditech Co. as applicant

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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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