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FDA 510(k)

VIDAS ESTRADIOL II (E2II) ASSAY

K-Number: K955647 · 1996-02-06

ApplicantBiomerieux Vitek, Inc.
Decision Date1996-02-06
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS ESTRADIOL II (E2II) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K955647. 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 VIDAS ESTRADIOL II (E2II) ASSAY?

VIDAS ESTRADIOL II (E2II) ASSAY is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K955647.

When did VIDAS ESTRADIOL II (E2II) ASSAY receive FDA 510(k) clearance?

VIDAS ESTRADIOL II (E2II) ASSAY received FDA 510(k) clearance on 1996-02-06, under 510(k) number K955647.

Who is the listed applicant for VIDAS ESTRADIOL II (E2II) ASSAY?

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

What is the FDA product code for VIDAS ESTRADIOL II (E2II) ASSAY?

The FDA product code for VIDAS ESTRADIOL II (E2II) ASSAY is CHP.

Related Clinical Trials

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Other records listing Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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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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