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FDA 510(k)

ONLINE DAT PROPOXYPHENE PLUS

K-Number: K043303 · 2005-03-11

ApplicantRoche Diagnostics Corp.
Decision Date2005-03-11
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE DAT PROPOXYPHENE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2005-03-11 under 510(k) number K043303. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE DAT PROPOXYPHENE PLUS?

ONLINE DAT PROPOXYPHENE PLUS is a medical device that received FDA 510(k) clearance on 2005-03-11. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043303.

When did ONLINE DAT PROPOXYPHENE PLUS receive FDA 510(k) clearance?

ONLINE DAT PROPOXYPHENE PLUS received FDA 510(k) clearance on 2005-03-11, under 510(k) number K043303.

Who is the listed applicant for ONLINE DAT PROPOXYPHENE PLUS?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONLINE DAT PROPOXYPHENE PLUS?

The FDA product code for ONLINE DAT PROPOXYPHENE PLUS is JXN.

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Related Devices (Code: JXN)

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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