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FDA 510(k)

ESTRIOL KIT

K-Number: K811380 · 1981-06-09

ApplicantCambridge Nuclear Corp.
Decision Date1981-06-09
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRIOL KIT 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 1981-06-09 under 510(k) number K811380. 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 ESTRIOL KIT?

ESTRIOL KIT is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Cambridge Nuclear Corp.. The 510(k) number is K811380.

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

ESTRIOL KIT received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811380.

Who is the listed applicant for ESTRIOL KIT?

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 ESTRIOL KIT?

The FDA product code for ESTRIOL KIT 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.

K810804PROGESTERONE KITK790362I BRADYKININ & ANTI-BRADYKININ ANTISERUMK790007I TESTOTERONEK790008I ESTRIOL

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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