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FDA 510(k)

IMMUNOREACTIVE ESTRIOL RIA KIT

K-Number: K802754 · 1981-01-21

ApplicantMicroanalytic Research, Inc.
Decision Date1981-01-21
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOREACTIVE ESTRIOL RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microanalytic Research, Inc.. It received FDA 510(k) clearance on 1981-01-21 under 510(k) number K802754. 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 IMMUNOREACTIVE ESTRIOL RIA KIT?

IMMUNOREACTIVE ESTRIOL RIA KIT is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Microanalytic Research, Inc.. The 510(k) number is K802754.

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

IMMUNOREACTIVE ESTRIOL RIA KIT received FDA 510(k) clearance on 1981-01-21, under 510(k) number K802754.

Who is the listed applicant for IMMUNOREACTIVE ESTRIOL RIA KIT?

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

What is the FDA product code for IMMUNOREACTIVE ESTRIOL RIA KIT?

The FDA product code for IMMUNOREACTIVE ESTRIOL RIA KIT is CGI.

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Other records listing Microanalytic Research, 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.

K861097TRYPSIN RIA KITK820741MR1 LUTROPIN RIA KITK820740MR1 FOLLITROPIN RIA KITK813516MRI TOBRAMYCIN RIA KITK812394MRI GENTAMICIN RIA KITK810949MRI PROLACTIN RIA 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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