FDA 510(k)

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

K-Number: K021316 · 2002-07-25

Decision Date2002-07-25

Product CodeLBS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2002-07-25 under 510(k) number K021316. 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 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR?

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR is a medical device that received FDA 510(k) clearance on 2002-07-25. The listed applicant is Genzyme Corp.. The 510(k) number is K021316.

When did ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR receive FDA 510(k) clearance?

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR received FDA 510(k) clearance on 2002-07-25, under 510(k) number K021316.

Who is the listed applicant for ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR?

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 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR?

The FDA product code for ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR is LBS.

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Related Devices (Code: LBS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.