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FDA 510(k)

N LATEX CDT

K-Number: K060677 · 2006-08-25

ApplicantDade Behring, Inc.
Decision Date2006-08-25
Product CodeNAO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N LATEX CDT 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 2006-08-25 under 510(k) number K060677. The device is classified under product code NAO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N LATEX CDT?

N LATEX CDT is a medical device that received FDA 510(k) clearance on 2006-08-25. The listed applicant is Dade Behring, Inc.. The 510(k) number is K060677.

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

N LATEX CDT received FDA 510(k) clearance on 2006-08-25, under 510(k) number K060677.

Who is the listed applicant for N LATEX CDT?

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 CDT?

The FDA product code for N LATEX CDT is NAO.

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Related Devices (Code: NAO)

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.

K001943CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYSangui Biotech, Inc.K992502AXIS %CDT TURBIDIMETRIC IMMUNOASSAYAxis

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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