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FDA 510(k)

IBL CORTISOL LIA TEST KIT

K-Number: K052359 · 2005-10-03

ApplicantLehnus & Associates Consulting
Decision Date2005-10-03
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IBL CORTISOL LIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lehnus & Associates Consulting. It received FDA 510(k) clearance on 2005-10-03 under 510(k) number K052359. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBL CORTISOL LIA TEST KIT?

IBL CORTISOL LIA TEST KIT is a medical device that received FDA 510(k) clearance on 2005-10-03. The listed applicant is Lehnus & Associates Consulting. The 510(k) number is K052359.

When did IBL CORTISOL LIA TEST KIT receive FDA 510(k) clearance?

IBL CORTISOL LIA TEST KIT received FDA 510(k) clearance on 2005-10-03, under 510(k) number K052359.

Who is the listed applicant for IBL CORTISOL LIA TEST KIT?

The FDA 510(k) record lists Lehnus & Associates Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBL CORTISOL LIA TEST KIT?

The FDA product code for IBL CORTISOL LIA TEST KIT is CGR.

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Other records listing Lehnus & Associates Consulting 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.

K103574PREGNANCY ONE STEP RAPID TEST

Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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