FDA 510(k)

TDX TOTAL ESTRIOL

K-Number: K844511 · 1985-01-18

Decision Date1985-01-18

Product CodeCGI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TDX TOTAL ESTRIOL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K844511. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX TOTAL ESTRIOL?

TDX TOTAL ESTRIOL is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Abbott Laboratories. The 510(k) number is K844511.

When did TDX TOTAL ESTRIOL receive FDA 510(k) clearance?

TDX TOTAL ESTRIOL received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844511.

Who is the listed applicant for TDX TOTAL ESTRIOL?

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 TDX TOTAL ESTRIOL?

The FDA product code for TDX TOTAL ESTRIOL is CGI.

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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.