FDA 510(k)

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

K-Number: K023795 · 2003-01-21

Decision Date2003-01-21

Product CodeJXN

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2003-01-21 under 510(k) number K023795. 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 PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)?

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) is a medical device that received FDA 510(k) clearance on 2003-01-21. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K023795.

When did PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) receive FDA 510(k) clearance?

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) received FDA 510(k) clearance on 2003-01-21, under 510(k) number K023795.

Who is the listed applicant for PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)?

The FDA product code for PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) is JXN.

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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.