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FDA 510(k)

ENZYGNOST F 1+2

K-Number: K922934 · 1992-11-16

ApplicantBehring Diagnostics, Inc.
Decision Date1992-11-16
Product CodeMIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST F 1+2 is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-11-16 under 510(k) number K922934. 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 1+2?

ENZYGNOST F 1+2 is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K922934.

When did ENZYGNOST F 1+2 receive FDA 510(k) clearance?

ENZYGNOST F 1+2 received FDA 510(k) clearance on 1992-11-16, under 510(k) number K922934.

Who is the listed applicant for ENZYGNOST F 1+2?

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

What is the FDA product code for ENZYGNOST F 1+2?

The FDA product code for ENZYGNOST F 1+2 is MIF.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: MIF)

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.

K042687ENZYGNOST F+2 (MONOCLONAL) TEST KITDade Behring, Inc.K964934THROMBONOSTIKA F1.2Organon Teknika Corp.K962176TPPPanbio, Inc.K920895DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISABaxter Diagnostics, Inc.K911434THROMBONOSTIKA F1.2Organon Teknika Corp.

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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