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FDA 510(k)

NORDICLAB ESTRADIOL RIA TEST

K-Number: K800920 · 1980-05-14

ApplicantNordiclab Intl.
Decision Date1980-05-14
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORDICLAB ESTRADIOL 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 1980-05-14 under 510(k) number K800920. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORDICLAB ESTRADIOL RIA TEST?

NORDICLAB ESTRADIOL RIA TEST is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Nordiclab Intl.. The 510(k) number is K800920.

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

NORDICLAB ESTRADIOL RIA TEST received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800920.

Who is the listed applicant for NORDICLAB ESTRADIOL 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 ESTRADIOL RIA TEST?

The FDA product code for NORDICLAB ESTRADIOL RIA TEST is CHP.

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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 TESTK800922NORDICLAB PROGESTERONE RIA TESTK800921NORDICLAB TESTOSTERONE RIA TESTK792189NORDICLAB TOTAL ESTRIOL RIA TESTK782157IRMA TEST, NORDICLAB FERRITIN

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Related Devices (Code: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, Inc.

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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