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FDA 510(k)

COTUBE ESTRADIOL RADIOIMMUNOASSAY

K-Number: K931740 · 1993-08-16

ApplicantBio-Rad
Decision Date1993-08-16
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COTUBE ESTRADIOL RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K931740. 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 COTUBE ESTRADIOL RADIOIMMUNOASSAY?

COTUBE ESTRADIOL RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Bio-Rad. The 510(k) number is K931740.

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

COTUBE ESTRADIOL RADIOIMMUNOASSAY received FDA 510(k) clearance on 1993-08-16, under 510(k) number K931740.

Who is the listed applicant for COTUBE ESTRADIOL RADIOIMMUNOASSAY?

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

What is the FDA product code for COTUBE ESTRADIOL RADIOIMMUNOASSAY?

The FDA product code for COTUBE ESTRADIOL RADIOIMMUNOASSAY is CHP.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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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