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FDA 510(k)

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

K-Number: K021498 · 2002-05-24

ApplicantBio-Rad
Decision Date2002-05-24
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2002-05-24 under 510(k) number K021498. 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 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL?

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Bio-Rad. The 510(k) number is K021498.

When did LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL receive FDA 510(k) clearance?

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL received FDA 510(k) clearance on 2002-05-24, under 510(k) number K021498.

Who is the listed applicant for LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL?

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

What is the FDA product code for LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL?

The FDA product code for LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL is JJT.

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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.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK012656LIQUICHEK 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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