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FDA 510(k)

FAST DIGOXIN TEST SYSTEM

K-Number: K924504 · 1993-01-13

ApplicantDiatron Corp.
Decision Date1993-01-13
Product CodeKXT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FAST DIGOXIN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diatron Corp.. It received FDA 510(k) clearance on 1993-01-13 under 510(k) number K924504. The device is classified under product code KXT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAST DIGOXIN TEST SYSTEM?

FAST DIGOXIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1993-01-13. The listed applicant is Diatron Corp.. The 510(k) number is K924504.

When did FAST DIGOXIN TEST SYSTEM receive FDA 510(k) clearance?

FAST DIGOXIN TEST SYSTEM received FDA 510(k) clearance on 1993-01-13, under 510(k) number K924504.

Who is the listed applicant for FAST DIGOXIN TEST SYSTEM?

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

What is the FDA product code for FAST DIGOXIN TEST SYSTEM?

The FDA product code for FAST DIGOXIN TEST SYSTEM is KXT.

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Related Devices (Code: KXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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