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FDA 510(k)

AURAFLEX(R) ESTRADIOL

K-Number: K946199 · 1995-04-03

ApplicantOrganon Teknika Corp.
Decision Date1995-04-03
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURAFLEX(R) ESTRADIOL is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1995-04-03 under 510(k) number K946199. 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 AURAFLEX(R) ESTRADIOL?

AURAFLEX(R) ESTRADIOL is a medical device that received FDA 510(k) clearance on 1995-04-03. The listed applicant is Organon Teknika Corp.. The 510(k) number is K946199.

When did AURAFLEX(R) ESTRADIOL receive FDA 510(k) clearance?

AURAFLEX(R) ESTRADIOL received FDA 510(k) clearance on 1995-04-03, under 510(k) number K946199.

Who is the listed applicant for AURAFLEX(R) ESTRADIOL?

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

What is the FDA product code for AURAFLEX(R) ESTRADIOL?

The FDA product code for AURAFLEX(R) ESTRADIOL is CHP.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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