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FDA 510(k)

ABBOTT AXSYM FOLATE

K-Number: K972232 · 1997-06-24

ApplicantAbbott Laboratories
Decision Date1997-06-24
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM FOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K972232. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT AXSYM FOLATE?

ABBOTT AXSYM FOLATE is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Abbott Laboratories. The 510(k) number is K972232.

When did ABBOTT AXSYM FOLATE receive FDA 510(k) clearance?

ABBOTT AXSYM FOLATE received FDA 510(k) clearance on 1997-06-24, under 510(k) number K972232.

Who is the listed applicant for ABBOTT AXSYM FOLATE?

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 AXSYM FOLATE?

The FDA product code for ABBOTT AXSYM FOLATE is CGN.

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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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