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FDA 510(k)

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

K-Number: K993715 · 1999-11-16

ApplicantSeracare Technology
Decision Date1999-11-16
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Seracare Technology. It received FDA 510(k) clearance on 1999-11-16 under 510(k) number K993715. 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 QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3?

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Seracare Technology. The 510(k) number is K993715.

When did QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 receive FDA 510(k) clearance?

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 received FDA 510(k) clearance on 1999-11-16, under 510(k) number K993715.

Who is the listed applicant for QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3?

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

What is the FDA product code for QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3?

The FDA product code for QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 is JJT.

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Other records listing Seracare Technology 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.

K992939QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3K993631QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2K992770QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3K992395URINE DRUG SCREENING CONTROL

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, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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