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FDA 510(k)

ELECSYS CORTISOL TEST SYSTEM

K-Number: K070788 · 2007-10-05

ApplicantRoche Diagnostics
Decision Date2007-10-05
Product CodeNHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CORTISOL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K070788. The device is classified under product code NHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CORTISOL TEST SYSTEM?

ELECSYS CORTISOL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Roche Diagnostics. The 510(k) number is K070788.

When did ELECSYS CORTISOL TEST SYSTEM receive FDA 510(k) clearance?

ELECSYS CORTISOL TEST SYSTEM received FDA 510(k) clearance on 2007-10-05, under 510(k) number K070788.

Who is the listed applicant for ELECSYS CORTISOL TEST SYSTEM?

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

What is the FDA product code for ELECSYS CORTISOL TEST SYSTEM?

The FDA product code for ELECSYS CORTISOL TEST SYSTEM is NHG.

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Other records listing Roche Diagnostics as applicant

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Related Devices (Code: NHG)

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.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYPantex, Div. Bio-Analysis, Inc.K051733ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOLDrg Intl., Inc.K043175ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPERoche Diagnostics Corp.K031348HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAYSalimetrics, LLCK011323HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102Salimetrics, LLC

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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