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FDA 510(k)

TDX AMPHETAMINE/METHAMPHETAMINE II

K-Number: K883707 · 1988-10-20

ApplicantAbbott Laboratories
Decision Date1988-10-20
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX AMPHETAMINE/METHAMPHETAMINE II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-10-20 under 510(k) number K883707. 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 AMPHETAMINE/METHAMPHETAMINE II?

TDX AMPHETAMINE/METHAMPHETAMINE II is a medical device that received FDA 510(k) clearance on 1988-10-20. The listed applicant is Abbott Laboratories. The 510(k) number is K883707.

When did TDX AMPHETAMINE/METHAMPHETAMINE II receive FDA 510(k) clearance?

TDX AMPHETAMINE/METHAMPHETAMINE II received FDA 510(k) clearance on 1988-10-20, under 510(k) number K883707.

Who is the listed applicant for TDX AMPHETAMINE/METHAMPHETAMINE II?

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 AMPHETAMINE/METHAMPHETAMINE II?

The FDA product code for TDX AMPHETAMINE/METHAMPHETAMINE II 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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