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FDA 510(k)

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY

K-Number: K031348 · 2003-06-10

ApplicantSalimetrics, LLC
Decision Date2003-06-10
Product CodeNHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Salimetrics, LLC. It received FDA 510(k) clearance on 2003-06-10 under 510(k) number K031348. 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 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY?

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2003-06-10. The listed applicant is Salimetrics, LLC. The 510(k) number is K031348.

When did HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2003-06-10, under 510(k) number K031348.

Who is the listed applicant for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY?

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

What is the FDA product code for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY?

The FDA product code for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY is NHG.

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Other records listing Salimetrics, LLC 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.

K051012PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.K011323HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102

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.K043175ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPERoche Diagnostics Corp.K011323HIGH 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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