FDA 510(k)

OPUS T3 CONTROLS

K-Number: K961206 · 1996-04-23

Decision Date1996-04-23

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

OPUS T3 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 1996-04-23 under 510(k) number K961206. 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 T3 CONTROLS?

OPUS T3 CONTROLS is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K961206.

When did OPUS T3 CONTROLS receive FDA 510(k) clearance?

OPUS T3 CONTROLS received FDA 510(k) clearance on 1996-04-23, under 510(k) number K961206.

Who is the listed applicant for OPUS T3 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 T3 CONTROLS?

The FDA product code for OPUS T3 CONTROLS is JJX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.