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FDA 510(k)

DAT TEST FOR CHAGAS' DISEASE

K-Number: K834328 · 1984-03-02

ApplicantSero-Immuno Diagnostics, Inc.
Decision Date1984-03-02
Product CodeGNE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DAT TEST FOR CHAGAS' DISEASE is the device name listed in this FDA 510(k) record. The listed applicant is Sero-Immuno Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-03-02 under 510(k) number K834328. The device is classified under product code GNE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAT TEST FOR CHAGAS' DISEASE?

DAT TEST FOR CHAGAS' DISEASE is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Sero-Immuno Diagnostics, Inc.. The 510(k) number is K834328.

When did DAT TEST FOR CHAGAS' DISEASE receive FDA 510(k) clearance?

DAT TEST FOR CHAGAS' DISEASE received FDA 510(k) clearance on 1984-03-02, under 510(k) number K834328.

Who is the listed applicant for DAT TEST FOR CHAGAS' DISEASE?

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

What is the FDA product code for DAT TEST FOR CHAGAS' DISEASE?

The FDA product code for DAT TEST FOR CHAGAS' DISEASE is GNE.

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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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