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FDA 510(k)

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

K-Number: K102841 · 2012-05-08

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date2012-05-08
Product CodeNHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K102841. 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 PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY?

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K102841.

When did PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2012-05-08, under 510(k) number K102841.

Who is the listed applicant for PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY?

The FDA product code for PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY is NHG.

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Other records listing Pantex, Div. Bio-Analysis, Inc. 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.

K070788ELECSYS CORTISOL TEST SYSTEMRoche DiagnosticsK051733ENZYME 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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