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FDA 510(k)

NATAL-TEC ESTRIOL

K-Number: K811371 · 1981-05-29

ApplicantArmkel, LLC
Decision Date1981-05-29
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NATAL-TEC ESTRIOL is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K811371. 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 NATAL-TEC ESTRIOL?

NATAL-TEC ESTRIOL is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is Armkel, LLC. The 510(k) number is K811371.

When did NATAL-TEC ESTRIOL receive FDA 510(k) clearance?

NATAL-TEC ESTRIOL received FDA 510(k) clearance on 1981-05-29, under 510(k) number K811371.

Who is the listed applicant for NATAL-TEC ESTRIOL?

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

What is the FDA product code for NATAL-TEC ESTRIOL?

The FDA product code for NATAL-TEC ESTRIOL is CGI.

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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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