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FDA 510(k)

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

K-Number: K991385 · 1999-10-25

ApplicantDade Behring, Inc.
Decision Date1999-10-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY 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 1999-10-25 under 510(k) number K991385. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE BEHRING N HIGH SENSITIVITY CRP ASSAY?

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Dade Behring, Inc.. The 510(k) number is K991385.

When did DADE BEHRING N HIGH SENSITIVITY CRP ASSAY receive FDA 510(k) clearance?

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY received FDA 510(k) clearance on 1999-10-25, under 510(k) number K991385.

Who is the listed applicant for DADE BEHRING N HIGH SENSITIVITY CRP ASSAY?

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 DADE BEHRING N HIGH SENSITIVITY CRP ASSAY?

The FDA product code for DADE BEHRING N HIGH SENSITIVITY CRP ASSAY is DCK.

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Related Devices (Code: DCK)

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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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