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FDA 510(k)

TOXO-G EIA DIAGNOSTIC KIT

K-Number: K840879 · 1984-05-21

ApplicantAbbott Laboratories
Decision Date1984-05-21
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXO-G EIA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K840879. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXO-G EIA DIAGNOSTIC KIT?

TOXO-G EIA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Abbott Laboratories. The 510(k) number is K840879.

When did TOXO-G EIA DIAGNOSTIC KIT receive FDA 510(k) clearance?

TOXO-G EIA DIAGNOSTIC KIT received FDA 510(k) clearance on 1984-05-21, under 510(k) number K840879.

Who is the listed applicant for TOXO-G EIA DIAGNOSTIC KIT?

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

What is the FDA product code for TOXO-G EIA DIAGNOSTIC KIT?

The FDA product code for TOXO-G EIA DIAGNOSTIC KIT is LGD.

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Related Devices (Code: LGD)

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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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