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FDA 510(k)

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

K-Number: K841947 · 1984-06-25

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1984-06-25
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1984-06-25 under 510(k) number K841947. 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 ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT?

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K841947.

When did ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1984-06-25, under 510(k) number K841947.

Who is the listed applicant for ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT?

The FDA product code for ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT is CHP.

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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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