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FDA 510(k)

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

K-Number: K051733 · 2005-12-07

ApplicantDrg Intl., Inc.
Decision Date2005-12-07
Product CodeNHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL is the device name listed in this FDA 510(k) record. The listed applicant is Drg Intl., Inc.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K051733. 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 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL?

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Drg Intl., Inc.. The 510(k) number is K051733.

When did ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL receive FDA 510(k) clearance?

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL received FDA 510(k) clearance on 2005-12-07, under 510(k) number K051733.

Who is the listed applicant for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL?

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

What is the FDA product code for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL?

The FDA product code for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL is NHG.

Related Clinical Trials

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Other records listing Drg Intl., 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.

K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEK052649DRG SLV TESTOSTERONE ELISA TESTK000043DRG AURICA ELISA TESTOSTERONE KIT

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 DiagnosticsK043175ELECSYS 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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