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FDA 510(k)

ADX(TM) ANALYZER

K-Number: K864566 · 1987-02-04

ApplicantAbbott Laboratories
Decision Date1987-02-04
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADX(TM) ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K864566. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADX(TM) ANALYZER?

ADX(TM) ANALYZER is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Abbott Laboratories. The 510(k) number is K864566.

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

ADX(TM) ANALYZER received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864566.

Who is the listed applicant for ADX(TM) ANALYZER?

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) ANALYZER?

The FDA product code for ADX(TM) ANALYZER is JJQ.

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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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