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FDA 510(k)

OPUS TROPONIN I

K-Number: K955284 · 1996-01-25

ApplicantBehring Diagnostics, Inc.
Decision Date1996-01-25
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS TROPONIN I 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 1996-01-25 under 510(k) number K955284. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS TROPONIN I?

OPUS TROPONIN I is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K955284.

When did OPUS TROPONIN I receive FDA 510(k) clearance?

OPUS TROPONIN I received FDA 510(k) clearance on 1996-01-25, under 510(k) number K955284.

Who is the listed applicant for OPUS TROPONIN I?

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 TROPONIN I?

The FDA product code for OPUS TROPONIN I is MMI.

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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.

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Related Devices (Code: MMI)

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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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