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FDA 510(k)

ADX TM OPIATES

K-Number: K890689 · 1989-08-25

ApplicantAbbott Laboratories
Decision Date1989-08-25
Product CodeDGJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADX TM OPIATES is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K890689. The device is classified under product code DGJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADX TM OPIATES?

ADX TM OPIATES is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Abbott Laboratories. The 510(k) number is K890689.

When did ADX TM OPIATES receive FDA 510(k) clearance?

ADX TM OPIATES received FDA 510(k) clearance on 1989-08-25, under 510(k) number K890689.

Who is the listed applicant for ADX TM OPIATES?

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 ADX TM OPIATES?

The FDA product code for ADX TM OPIATES is DGJ.

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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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