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FDA 510(k)

RIA KIT, GAMMADAB ESTRIOL

K-Number: K781938 · 1979-01-10

ApplicantClinical Assays, Inc.
Decision Date1979-01-10
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA KIT, GAMMADAB ESTRIOL is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781938. 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 RIA KIT, GAMMADAB ESTRIOL?

RIA KIT, GAMMADAB ESTRIOL is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K781938.

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

RIA KIT, GAMMADAB ESTRIOL received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781938.

Who is the listed applicant for RIA KIT, GAMMADAB ESTRIOL?

The FDA 510(k) record lists Clinical Assays, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA KIT, GAMMADAB ESTRIOL?

The FDA product code for RIA KIT, GAMMADAB ESTRIOL is CGI.

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Other records listing Clinical Assays, Inc. 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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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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