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FDA 510(k)

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL

K-Number: K920576 · 1992-03-23

ApplicantEastman Kodak Company
Decision Date1992-03-23
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1992-03-23 under 510(k) number K920576. 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 AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL?

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL is a medical device that received FDA 510(k) clearance on 1992-03-23. The listed applicant is Eastman Kodak Company. The 510(k) number is K920576.

When did AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL receive FDA 510(k) clearance?

AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL received FDA 510(k) clearance on 1992-03-23, under 510(k) number K920576.

Who is the listed applicant for AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL?

The FDA 510(k) record lists Eastman Kodak Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL?

The FDA product code for AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL is CGI.

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Other records listing Eastman Kodak Company as applicant

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K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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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 OYK903359MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KITImmunotech Corp.

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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