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FDA 510(k)

OPUS MYOGLOBIN CONTROLS

K-Number: K962841 · 1996-08-15

ApplicantBehring Diagnostics, Inc.
Decision Date1996-08-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS MYOGLOBIN CONTROLS 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 1996-08-15 under 510(k) number K962841. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS MYOGLOBIN CONTROLS?

OPUS MYOGLOBIN CONTROLS is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K962841.

When did OPUS MYOGLOBIN CONTROLS receive FDA 510(k) clearance?

OPUS MYOGLOBIN CONTROLS received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962841.

Who is the listed applicant for OPUS MYOGLOBIN CONTROLS?

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 MYOGLOBIN CONTROLS?

The FDA product code for OPUS MYOGLOBIN CONTROLS is JJX.

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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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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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