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FDA 510(k)

ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER

K-Number: K974779 · 1998-02-13

ApplicantAbbott Laboratories
Decision Date1998-02-13
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 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 1998-02-13 under 510(k) number K974779. 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 ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER?

ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Abbott Laboratories. The 510(k) number is K974779.

When did ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER receive FDA 510(k) clearance?

ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974779.

Who is the listed applicant for ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 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 ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER?

The FDA product code for ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER is JJE.

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Related Devices (Code: 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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