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FDA 510(k)

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

K-Number: K943150 · 1995-03-15

ApplicantGenzyme Corp.
Decision Date1995-03-15
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1995-03-15 under 510(k) number K943150. 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 IMMUNOSEPARATION REAGENT KIT?

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is Genzyme Corp.. The 510(k) number is K943150.

When did DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT receive FDA 510(k) clearance?

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT received FDA 510(k) clearance on 1995-03-15, under 510(k) number K943150.

Who is the listed applicant for DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT?

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

What is the FDA product code for DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT?

The FDA product code for DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT is MRR.

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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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