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FDA 510(k)

HDL CHOLESTEROL REAGENT, MODEL 10211

K-Number: K073497 · 2008-04-14

ApplicantMedica Corp.
Decision Date2008-04-14
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL CHOLESTEROL REAGENT, MODEL 10211 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2008-04-14 under 510(k) number K073497. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL CHOLESTEROL REAGENT, MODEL 10211?

HDL CHOLESTEROL REAGENT, MODEL 10211 is a medical device that received FDA 510(k) clearance on 2008-04-14. The listed applicant is Medica Corp.. The 510(k) number is K073497.

When did HDL CHOLESTEROL REAGENT, MODEL 10211 receive FDA 510(k) clearance?

HDL CHOLESTEROL REAGENT, MODEL 10211 received FDA 510(k) clearance on 2008-04-14, under 510(k) number K073497.

Who is the listed applicant for HDL CHOLESTEROL REAGENT, MODEL 10211?

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

What is the FDA product code for HDL CHOLESTEROL REAGENT, MODEL 10211?

The FDA product code for HDL CHOLESTEROL REAGENT, MODEL 10211 is LBS.

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Other records listing Medica 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.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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