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FDA 510(k)

OPUS ETHANOL

K-Number: K972011 · 1997-07-22

ApplicantBehring Diagnostics, Inc.
Decision Date1997-07-22
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPUS ETHANOL 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 1997-07-22 under 510(k) number K972011. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS ETHANOL?

OPUS ETHANOL is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K972011.

When did OPUS ETHANOL receive FDA 510(k) clearance?

OPUS ETHANOL received FDA 510(k) clearance on 1997-07-22, under 510(k) number K972011.

Who is the listed applicant for OPUS ETHANOL?

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 OPUS ETHANOL?

The FDA product code for OPUS ETHANOL is DIC.

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Other records listing Behring Diagnostics, Inc. as applicant

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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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Related Devices (Code: DIC)

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.

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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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