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FDA 510(k)

NORDICLAB TOTAL ESTRIOL RIA TEST

K-Number: K792189 · 1979-11-13

ApplicantNordiclab Intl.
Decision Date1979-11-13
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORDICLAB TOTAL ESTRIOL RIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nordiclab Intl.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792189. 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 NORDICLAB TOTAL ESTRIOL RIA TEST?

NORDICLAB TOTAL ESTRIOL RIA TEST is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Nordiclab Intl.. The 510(k) number is K792189.

When did NORDICLAB TOTAL ESTRIOL RIA TEST receive FDA 510(k) clearance?

NORDICLAB TOTAL ESTRIOL RIA TEST received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792189.

Who is the listed applicant for NORDICLAB TOTAL ESTRIOL RIA TEST?

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

What is the FDA product code for NORDICLAB TOTAL ESTRIOL RIA TEST?

The FDA product code for NORDICLAB TOTAL ESTRIOL RIA TEST is CGI.

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Other records listing Nordiclab Intl. 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.

K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIAK801989NORDICLAB FERRITIN IRMA TESTK800920NORDICLAB ESTRADIOL RIA TESTK800922NORDICLAB PROGESTERONE RIA TESTK800921NORDICLAB TESTOSTERONE RIA TESTK782157IRMA TEST, NORDICLAB FERRITIN

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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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