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FDA 510(k)

DIRECT LDL CHOLESTEROL, MODEL L530-60H

K-Number: K051121 · 2005-08-08

ApplicantTeco Diagnostics
Decision Date2005-08-08
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT LDL CHOLESTEROL, MODEL L530-60H is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2005-08-08 under 510(k) number K051121. 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 DIRECT LDL CHOLESTEROL, MODEL L530-60H?

DIRECT LDL CHOLESTEROL, MODEL L530-60H is a medical device that received FDA 510(k) clearance on 2005-08-08. The listed applicant is Teco Diagnostics. The 510(k) number is K051121.

When did DIRECT LDL CHOLESTEROL, MODEL L530-60H receive FDA 510(k) clearance?

DIRECT LDL CHOLESTEROL, MODEL L530-60H received FDA 510(k) clearance on 2005-08-08, under 510(k) number K051121.

Who is the listed applicant for DIRECT LDL CHOLESTEROL, MODEL L530-60H?

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

What is the FDA product code for DIRECT LDL CHOLESTEROL, MODEL L530-60H?

The FDA product code for DIRECT LDL CHOLESTEROL, MODEL L530-60H is MRR.

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Other records listing Teco Diagnostics as applicant

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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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