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FDA 510(k)

OPUS HCG CONTROLS

K-Number: K954144 · 1995-10-06

ApplicantBehring Diagnostics, Inc.
Decision Date1995-10-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS HCG 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 1995-10-06 under 510(k) number K954144. 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 HCG CONTROLS?

OPUS HCG CONTROLS is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K954144.

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

OPUS HCG CONTROLS received FDA 510(k) clearance on 1995-10-06, under 510(k) number K954144.

Who is the listed applicant for OPUS HCG 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 HCG CONTROLS?

The FDA product code for OPUS HCG 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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Related Devices (Code: JJX)

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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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