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FDA 510(k)

ESTRIOL-SQUIBB RIA KIT

K-Number: K802455 · 1980-10-31

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1980-10-31
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRIOL-SQUIBB RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is E. R. Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802455. 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 ESTRIOL-SQUIBB RIA KIT?

ESTRIOL-SQUIBB RIA KIT is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K802455.

When did ESTRIOL-SQUIBB RIA KIT receive FDA 510(k) clearance?

ESTRIOL-SQUIBB RIA KIT received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802455.

Who is the listed applicant for ESTRIOL-SQUIBB RIA KIT?

The FDA 510(k) record lists E. R. Squibb & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTRIOL-SQUIBB RIA KIT?

The FDA product code for ESTRIOL-SQUIBB RIA KIT is CGI.

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Other records listing E. R. Squibb & Sons, 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.

K821494RIA STAT 16K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYK820341CORTISOL-SQUIBB RADIOIMMUNOASSAY KITK820340T3 UPTAKE-SQUIBB DIAGNOSTIC KITK811240SUR-FIT LOOP OSTOMY O.R. SETK811239SUR-FIT DISPOSABLE CONVEX INSERT

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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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