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FDA 510(k)

AXSYM AMPHETAMINE/METHAMPHETAMINE II

K-Number: K953115 · 1995-10-06

ApplicantAbbott Laboratories
Decision Date1995-10-06
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM 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 1995-10-06 under 510(k) number K953115. 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 AXSYM AMPHETAMINE/METHAMPHETAMINE II?

AXSYM AMPHETAMINE/METHAMPHETAMINE II is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Abbott Laboratories. The 510(k) number is K953115.

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

AXSYM AMPHETAMINE/METHAMPHETAMINE II received FDA 510(k) clearance on 1995-10-06, under 510(k) number K953115.

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

The FDA product code for AXSYM AMPHETAMINE/METHAMPHETAMINE II is DKZ.

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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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