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FDA 510(k)

IMX SELECT ANALYZER

K-Number: K912368 · 1991-09-11

ApplicantAbbott Laboratories
Decision Date1991-09-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX SELECT 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 1991-09-11 under 510(k) number K912368. 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 IMX SELECT ANALYZER?

IMX SELECT ANALYZER is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Abbott Laboratories. The 510(k) number is K912368.

When did IMX SELECT ANALYZER receive FDA 510(k) clearance?

IMX SELECT ANALYZER received FDA 510(k) clearance on 1991-09-11, under 510(k) number K912368.

Who is the listed applicant for IMX SELECT 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 IMX SELECT ANALYZER?

The FDA product code for IMX SELECT 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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