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FDA 510(k)

DIGOXIN & PHENYTOIN CONTROL SERA

K-Number: K803097 · 1980-12-22

ApplicantAmersham Corp.
Decision Date1980-12-22
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGOXIN & PHENYTOIN CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803097. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGOXIN & PHENYTOIN CONTROL SERA?

DIGOXIN & PHENYTOIN CONTROL SERA is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Amersham Corp.. The 510(k) number is K803097.

When did DIGOXIN & PHENYTOIN CONTROL SERA receive FDA 510(k) clearance?

DIGOXIN & PHENYTOIN CONTROL SERA received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803097.

Who is the listed applicant for DIGOXIN & PHENYTOIN CONTROL SERA?

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

What is the FDA product code for DIGOXIN & PHENYTOIN CONTROL SERA?

The FDA product code for DIGOXIN & PHENYTOIN CONTROL SERA is DIF.

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Related Devices (Code: DIF)

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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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