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FDA 510(k)

CORTISOL LIA

K-Number: K010790 · 2002-01-29

ApplicantKmi Diagnostics, Inc.
Decision Date2002-01-29
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL LIA is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-01-29 under 510(k) number K010790. 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 CORTISOL LIA?

CORTISOL LIA is a medical device that received FDA 510(k) clearance on 2002-01-29. The listed applicant is Kmi Diagnostics, Inc.. The 510(k) number is K010790.

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

CORTISOL LIA received FDA 510(k) clearance on 2002-01-29, under 510(k) number K010790.

Who is the listed applicant for CORTISOL LIA?

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

What is the FDA product code for CORTISOL LIA?

The FDA product code for CORTISOL LIA is CGR.

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Other records listing Kmi Diagnostics, 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.

K990073CALCITONINK973900TESTOTERONE ELISAK97390117 B-ESTRADIOL (ELISA)K973897DHEA-SK973898PROGESTERONE ELISA

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.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K202826IMMULITE® 2000 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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