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FDA 510(k)

ABBOTT TDT EIA

K-Number: K843908 · 1985-04-03

Decision Date1985-04-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT TDT EIA is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K843908. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TDT EIA?

ABBOTT TDT EIA is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Abbott Laboratories. The 510(k) number is K843908.

When did ABBOTT TDT EIA receive FDA 510(k) clearance?

ABBOTT TDT EIA received FDA 510(k) clearance on 1985-04-03, under 510(k) number K843908.

Who is the listed applicant for ABBOTT TDT EIA?

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 ABBOTT TDT EIA?

The FDA product code for ABBOTT TDT EIA is CIG.

Related Clinical Trials

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.

Other records listing Abbott Laboratories as applicant

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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Related Devices (Code: CIG)

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.

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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