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FDA 510(k)

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

K-Number: K050823 · 2005-07-26

ApplicantTeco Diagnostics
Decision Date2005-07-26
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2005-07-26 under 510(k) number K050823. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR?

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR is a medical device that received FDA 510(k) clearance on 2005-07-26. The listed applicant is Teco Diagnostics. The 510(k) number is K050823.

When did DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR receive FDA 510(k) clearance?

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR received FDA 510(k) clearance on 2005-07-26, under 510(k) number K050823.

Who is the listed applicant for DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR?

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 HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR?

The FDA product code for DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR is LBR.

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Other records listing Teco 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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Related Devices (Code: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Holdings, 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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