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FDA 510(k)

CENTRIA CORTISOL RIA

K-Number: K771117 · 1977-06-23

ApplicantClinical Diagnostics, Inc.
Decision Date1977-06-23
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIA CORTISOL RIA is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-06-23 under 510(k) number K771117. 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 CENTRIA CORTISOL RIA?

CENTRIA CORTISOL RIA is a medical device that received FDA 510(k) clearance on 1977-06-23. The listed applicant is Clinical Diagnostics, Inc.. The 510(k) number is K771117.

When did CENTRIA CORTISOL RIA receive FDA 510(k) clearance?

CENTRIA CORTISOL RIA received FDA 510(k) clearance on 1977-06-23, under 510(k) number K771117.

Who is the listed applicant for CENTRIA CORTISOL RIA?

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

What is the FDA product code for CENTRIA CORTISOL RIA?

The FDA product code for CENTRIA CORTISOL RIA is CGR.

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Other records listing Clinical Diagnostics, Inc. as applicant

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K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEMK951457GLUCOCHEK POCKETLABK940215GLUCOCHEKK854903GORDON DIAGNOSTIC SYSTEM MODEL IK771813CENTRIFICHEM SYS 400 ANALYZERK771118CENTRIA SEPARATION COLUMNS TYPE A

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Related Devices (Code: CGR)

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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

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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