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FDA 510(k)

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K-Number: K062751 · 2006-10-03

ApplicantQuantimetrix Corp.
Decision Date2006-10-03
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2006-10-03 under 510(k) number K062751. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER?

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER is a medical device that received FDA 510(k) clearance on 2006-10-03. The listed applicant is Quantimetrix Corp.. The 510(k) number is K062751.

When did MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER receive FDA 510(k) clearance?

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER received FDA 510(k) clearance on 2006-10-03, under 510(k) number K062751.

Who is the listed applicant for MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER?

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

What is the FDA product code for MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER?

The FDA product code for MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER is JJT.

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Other records listing Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROLK030826PRECISET DAT AMPHETAMINE

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Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-RadK993723CARDIASURE CARDIAC MARKERS CONTROLQuantimetrix Corp.

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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