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FDA 510(k)

NANO-CHECK AMI CTNI CARDIAC MARKER TEST

K-Number: K102131 · 2010-10-20

ApplicantNano-Ditech Corporation
Decision Date2010-10-20
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NANO-CHECK AMI CTNI CARDIAC MARKER TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nano-Ditech Corporation. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K102131. 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 CTNI CARDIAC MARKER TEST?

NANO-CHECK AMI CTNI CARDIAC MARKER TEST is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K102131.

When did NANO-CHECK AMI CTNI CARDIAC MARKER TEST receive FDA 510(k) clearance?

NANO-CHECK AMI CTNI CARDIAC MARKER TEST received FDA 510(k) clearance on 2010-10-20, under 510(k) number K102131.

Who is the listed applicant for NANO-CHECK AMI CTNI CARDIAC MARKER TEST?

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

What is the FDA product code for NANO-CHECK AMI CTNI CARDIAC MARKER TEST?

The FDA product code for NANO-CHECK AMI CTNI CARDIAC MARKER TEST is MMI.

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Other records listing Nano-Ditech Corporation 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.

K252283Nano-Check Influenza A+B TestK243561Nano-Check Influenza+COVID-19 Dual TestK240280Nano-Check™ RSV TestK231187Nano-Check™ COVID-19 Antigen TestK102441NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

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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