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FDA 510(k)

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

K-Number: K043175 · 2004-11-24

ApplicantRoche Diagnostics Corp.
Decision Date2004-11-24
Product CodeNHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K043175. 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, ADDITION OF SALIVA SAMPLE TYPE?

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K043175.

When did ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE receive FDA 510(k) clearance?

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE received FDA 510(k) clearance on 2004-11-24, under 510(k) number K043175.

Who is the listed applicant for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE?

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

What is the FDA product code for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE?

The FDA product code for ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE is NHG.

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Other records listing Roche Diagnostics 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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.K070788ELECSYS CORTISOL TEST SYSTEMRoche DiagnosticsK051733ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOLDrg Intl., Inc.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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