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FDA 510(k)

QUANTIMUNE ESTRIOL RIA

K-Number: K811709 · 1981-07-10

ApplicantBio-Rad
Decision Date1981-07-10
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE ESTRIOL RIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811709. 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 QUANTIMUNE ESTRIOL RIA?

QUANTIMUNE ESTRIOL RIA is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Bio-Rad. The 510(k) number is K811709.

When did QUANTIMUNE ESTRIOL RIA receive FDA 510(k) clearance?

QUANTIMUNE ESTRIOL RIA received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811709.

Who is the listed applicant for QUANTIMUNE ESTRIOL RIA?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIMUNE ESTRIOL RIA?

The FDA product code for QUANTIMUNE ESTRIOL RIA is CGI.

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Other records listing Bio-Rad 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: 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

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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