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FDA 510(k)

CIBA CORNING ACS CORTISOL IMMUNOASSAY

K-Number: K945367 · 1995-05-05

ApplicantCiba Corning Diagnostics Corp.
Decision Date1995-05-05
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS CORTISOL IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K945367. 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 CIBA CORNING ACS CORTISOL IMMUNOASSAY?

CIBA CORNING ACS CORTISOL IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K945367.

When did CIBA CORNING ACS CORTISOL IMMUNOASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS CORTISOL IMMUNOASSAY received FDA 510(k) clearance on 1995-05-05, under 510(k) number K945367.

Who is the listed applicant for CIBA CORNING ACS CORTISOL IMMUNOASSAY?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIBA CORNING ACS CORTISOL IMMUNOASSAY?

The FDA product code for CIBA CORNING ACS CORTISOL IMMUNOASSAY is CGR.

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Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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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

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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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