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FDA 510(k)

TDX (R) AMPHETAMINE CLASS

K-Number: K874770 · 1988-04-21

ApplicantAbbott Laboratories
Decision Date1988-04-21
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX (R) AMPHETAMINE CLASS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K874770. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX (R) AMPHETAMINE CLASS?

TDX (R) AMPHETAMINE CLASS is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Abbott Laboratories. The 510(k) number is K874770.

When did TDX (R) AMPHETAMINE CLASS receive FDA 510(k) clearance?

TDX (R) AMPHETAMINE CLASS received FDA 510(k) clearance on 1988-04-21, under 510(k) number K874770.

Who is the listed applicant for TDX (R) AMPHETAMINE CLASS?

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) AMPHETAMINE CLASS?

The FDA product code for TDX (R) AMPHETAMINE CLASS is DKZ.

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Related Devices (Code: DKZ)

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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