FDA 510(k)

CYBREX PHENYTOIN

K-Number: K801565 · 1980-07-21

Decision Date1980-07-21

Product Code

DecisionSubstantially Equivalent

Device Summary

CYBREX PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801565. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBREX PHENYTOIN?

CYBREX PHENYTOIN is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Abbott Laboratories. The 510(k) number is K801565.

When did CYBREX PHENYTOIN receive FDA 510(k) clearance?

CYBREX PHENYTOIN received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801565.

Who is the listed applicant for CYBREX PHENYTOIN?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.