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FDA 510(k)

PRECISET DAT PLUS

K-Number: K021393 · 2002-06-13

ApplicantQuantimetrix Corp.
Decision Date2002-06-13
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PRECISET DAT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K021393. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISET DAT PLUS?

PRECISET DAT PLUS is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Quantimetrix Corp.. The 510(k) number is K021393.

When did PRECISET DAT PLUS receive FDA 510(k) clearance?

PRECISET DAT PLUS received FDA 510(k) clearance on 2002-06-13, under 510(k) number K021393.

Who is the listed applicant for PRECISET DAT PLUS?

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 PRECISET DAT PLUS?

The FDA product code for PRECISET DAT PLUS is DKB.

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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 CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, 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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