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FDA 510(k)

N LATEX CYSTATIN

K-Number: K041878 · 2004-08-16

ApplicantDade Behring, Inc.
Decision Date2004-08-16
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N LATEX CYSTATIN is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K041878. 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 N LATEX CYSTATIN?

N LATEX CYSTATIN is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K041878.

When did N LATEX CYSTATIN receive FDA 510(k) clearance?

N LATEX CYSTATIN received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041878.

Who is the listed applicant for N LATEX CYSTATIN?

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

What is the FDA product code for N LATEX CYSTATIN?

The FDA product code for N LATEX CYSTATIN is NDY.

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Related Devices (Code: NDY)

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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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