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FDA 510(k)

IMX ESTRADIOL

K-Number: K951629 · 1995-05-17

ApplicantAbbott Laboratories
Decision Date1995-05-17
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMX ESTRADIOL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K951629. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMX ESTRADIOL?

IMX ESTRADIOL is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Abbott Laboratories. The 510(k) number is K951629.

When did IMX ESTRADIOL receive FDA 510(k) clearance?

IMX ESTRADIOL received FDA 510(k) clearance on 1995-05-17, under 510(k) number K951629.

Who is the listed applicant for IMX ESTRADIOL?

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 IMX ESTRADIOL?

The FDA product code for IMX ESTRADIOL is JIS.

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Related Devices (Code: JIS)

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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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