FDA 510(k)

MICROMEDIC ESTRIOL RIA KIT

K-Number: K822578 · 1982-10-26

Decision Date1982-10-26

Product CodeCGI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MICROMEDIC ESTRIOL RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1982-10-26 under 510(k) number K822578. 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 MICROMEDIC ESTRIOL RIA KIT?

MICROMEDIC ESTRIOL RIA KIT is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is Micromedic Systems. The 510(k) number is K822578.

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

MICROMEDIC ESTRIOL RIA KIT received FDA 510(k) clearance on 1982-10-26, under 510(k) number K822578.

Who is the listed applicant for MICROMEDIC ESTRIOL RIA KIT?

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

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

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

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Other records listing Micromedic Systems as applicant

K923643MEDICOOL K872309MICROMEDIC COMBOSTAT LH/FSH KIT K871008MICROMEDIC NEONATAL T4 KIT K870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT K871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT K870245AUTOPAK TSH MONOCLONAL IRMA KIT

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Related Devices (Code: CGI)

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 OY K920576AMERLEX-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.