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FDA 510(k)

ENZYGNOST F+2 (MONOCLONAL) TEST KIT

K-Number: K042687 · 2004-12-10

ApplicantDade Behring, Inc.
Decision Date2004-12-10
Product CodeMIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST F+2 (MONOCLONAL) TEST KIT 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 2004-12-10 under 510(k) number K042687. The device is classified under product code MIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYGNOST F+2 (MONOCLONAL) TEST KIT?

ENZYGNOST F+2 (MONOCLONAL) TEST KIT is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Dade Behring, Inc.. The 510(k) number is K042687.

When did ENZYGNOST F+2 (MONOCLONAL) TEST KIT receive FDA 510(k) clearance?

ENZYGNOST F+2 (MONOCLONAL) TEST KIT received FDA 510(k) clearance on 2004-12-10, under 510(k) number K042687.

Who is the listed applicant for ENZYGNOST F+2 (MONOCLONAL) TEST KIT?

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 ENZYGNOST F+2 (MONOCLONAL) TEST KIT?

The FDA product code for ENZYGNOST F+2 (MONOCLONAL) TEST KIT is MIF.

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Related Devices (Code: MIF)

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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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