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FDA 510(k)

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS

K-Number: K912365 · 1991-08-16

ApplicantAbbott Laboratories
Decision Date1991-08-16
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912365. 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 TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS?

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Abbott Laboratories. The 510(k) number is K912365.

When did TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS receive FDA 510(k) clearance?

TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912365.

Who is the listed applicant for TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS?

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

What is the FDA product code for TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS?

The FDA product code for TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS 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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