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FDA 510(k)

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

K-Number: K020575 · 2002-04-12

ApplicantElan Diagnostics
Decision Date2002-04-12
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K020575. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS?

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Elan Diagnostics. The 510(k) number is K020575.

When did ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS receive FDA 510(k) clearance?

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS received FDA 510(k) clearance on 2002-04-12, under 510(k) number K020575.

Who is the listed applicant for ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS?

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

What is the FDA product code for ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS?

The FDA product code for ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS is MRR.

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Other records listing Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030006ATAC PAK ALBUMIN REAGENT

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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