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FDA 510(k)

ALCYON 300I (WITH ISE MODULE) ANALYZER

K-Number: K993083 · 1999-10-05

ApplicantAbbott Laboratories
Decision Date1999-10-05
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALCYON 300I (WITH ISE MODULE) 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 1999-10-05 under 510(k) number K993083. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCYON 300I (WITH ISE MODULE) ANALYZER?

ALCYON 300I (WITH ISE MODULE) ANALYZER is a medical device that received FDA 510(k) clearance on 1999-10-05. The listed applicant is Abbott Laboratories. The 510(k) number is K993083.

When did ALCYON 300I (WITH ISE MODULE) ANALYZER receive FDA 510(k) clearance?

ALCYON 300I (WITH ISE MODULE) ANALYZER received FDA 510(k) clearance on 1999-10-05, under 510(k) number K993083.

Who is the listed applicant for ALCYON 300I (WITH ISE MODULE) 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 ALCYON 300I (WITH ISE MODULE) ANALYZER?

The FDA product code for ALCYON 300I (WITH ISE MODULE) ANALYZER is CEM.

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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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