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FDA 510(k)

I-ESTRIOL TEST SET

K-Number: K781599 · 1978-10-17

ApplicantWien Laboratories, Inc.
Decision Date1978-10-17
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-ESTRIOL TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781599. 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 I-ESTRIOL TEST SET?

I-ESTRIOL TEST SET is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K781599.

When did I-ESTRIOL TEST SET receive FDA 510(k) clearance?

I-ESTRIOL TEST SET received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781599.

Who is the listed applicant for I-ESTRIOL TEST SET?

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

What is the FDA product code for I-ESTRIOL TEST SET?

The FDA product code for I-ESTRIOL TEST SET is CGI.

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Other records listing Wien Laboratories, Inc. as applicant

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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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