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FDA 510(k)

I ESTRIOL

K-Number: K790008 · 1979-02-26

ApplicantCambridge Nuclear Corp.
Decision Date1979-02-26
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I ESTRIOL is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Nuclear Corp.. It received FDA 510(k) clearance on 1979-02-26 under 510(k) number K790008. 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 I ESTRIOL?

I ESTRIOL is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Cambridge Nuclear Corp.. The 510(k) number is K790008.

When did I ESTRIOL receive FDA 510(k) clearance?

I ESTRIOL received FDA 510(k) clearance on 1979-02-26, under 510(k) number K790008.

Who is the listed applicant for I ESTRIOL?

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

What is the FDA product code for I ESTRIOL?

The FDA product code for I ESTRIOL is CGI.

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.

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Other records listing Cambridge Nuclear Corp. 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.

K811380ESTRIOL KITK810804PROGESTERONE KITK790362I BRADYKININ & ANTI-BRADYKININ ANTISERUMK790007I TESTOTERONE

Related Devices (Code: CGI)

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.

K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company

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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