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FDA 510(k)

HDL CHOLESTEROL PRECIPITATING REAGENT

K-Number: K880176 · 1988-02-18

ApplicantTech-Co, Inc.
Decision Date1988-02-18
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL CHOLESTEROL PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-02-18 under 510(k) number K880176. 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 HDL CHOLESTEROL PRECIPITATING REAGENT?

HDL CHOLESTEROL PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Tech-Co, Inc.. The 510(k) number is K880176.

When did HDL CHOLESTEROL PRECIPITATING REAGENT receive FDA 510(k) clearance?

HDL CHOLESTEROL PRECIPITATING REAGENT received FDA 510(k) clearance on 1988-02-18, under 510(k) number K880176.

Who is the listed applicant for HDL CHOLESTEROL PRECIPITATING REAGENT?

The FDA 510(k) record lists Tech-Co, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL CHOLESTEROL PRECIPITATING REAGENT?

The FDA product code for HDL CHOLESTEROL PRECIPITATING REAGENT is LBR.

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Other records listing Tech-Co, Inc. 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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 AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM 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.,

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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