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FDA 510(k)

ESTRIOL RADIOIMMUNOASSAY TEST KIT

K-Number: K810695 · 1981-03-31

ApplicantSerono Laboratories, Inc.
Decision Date1981-03-31
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRIOL RADIOIMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810695. 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 ESTRIOL RADIOIMMUNOASSAY TEST KIT?

ESTRIOL RADIOIMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K810695.

When did ESTRIOL RADIOIMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

ESTRIOL RADIOIMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810695.

Who is the listed applicant for ESTRIOL RADIOIMMUNOASSAY TEST KIT?

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

What is the FDA product code for ESTRIOL RADIOIMMUNOASSAY TEST KIT?

The FDA product code for ESTRIOL RADIOIMMUNOASSAY TEST KIT is CHP.

Related Clinical Trials

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.

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Other records listing Serono Laboratories, 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.

K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITK810625HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-K792043PAP-CHECK RIA KITK790679ESTRADIOL RIA KITK790440PROGESTERONEK782143RIA KIT, GLUCOSE

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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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