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FDA 510(k)

ADD-1

K-Number: K844114 · 1984-11-27

ApplicantAbbott Laboratories
Decision Date1984-11-27
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADD-1 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K844114. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD-1?

ADD-1 is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Abbott Laboratories. The 510(k) number is K844114.

When did ADD-1 receive FDA 510(k) clearance?

ADD-1 received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844114.

Who is the listed applicant for ADD-1?

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 ADD-1?

The FDA product code for ADD-1 is JJE.

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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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