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FDA 510(k)

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

K-Number: K080662 · 2008-05-15

ApplicantGenzyme Corporation
Decision Date2008-05-15
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080662. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR?

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Genzyme Corporation. The 510(k) number is K080662.

When did GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR receive FDA 510(k) clearance?

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080662.

Who is the listed applicant for GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR?

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

What is the FDA product code for GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR?

The FDA product code for GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR is NDY.

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Related Devices (Code: NDY)

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.

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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.

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