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FDA 510(k)

TEST, RIA, SERUM DIGOXIN

K-Number: K760077 · 1976-07-16

ApplicantSmithkline Diagnostics, Inc.
Decision Date1976-07-16
Product CodeDND
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TEST, RIA, SERUM DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-07-16 under 510(k) number K760077. The device is classified under product code DND. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, RIA, SERUM DIGOXIN?

TEST, RIA, SERUM DIGOXIN is a medical device that received FDA 510(k) clearance on 1976-07-16. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K760077.

When did TEST, RIA, SERUM DIGOXIN receive FDA 510(k) clearance?

TEST, RIA, SERUM DIGOXIN received FDA 510(k) clearance on 1976-07-16, under 510(k) number K760077.

Who is the listed applicant for TEST, RIA, SERUM DIGOXIN?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEST, RIA, SERUM DIGOXIN?

The FDA product code for TEST, RIA, SERUM DIGOXIN is DND.

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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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