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FDA 510(k)

ACS CORTISOL IMMUNOASSAY

K-Number: K962559 · 1996-11-05

ApplicantCiba Corning Diagnostics Corp.
Decision Date1996-11-05
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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 1996-11-05 under 510(k) number K962559. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS CORTISOL IMMUNOASSAY?

ACS CORTISOL IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1996-11-05. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K962559.

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

ACS CORTISOL IMMUNOASSAY received FDA 510(k) clearance on 1996-11-05, under 510(k) number K962559.

Who is the listed applicant for 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 ACS CORTISOL IMMUNOASSAY?

The FDA product code for ACS CORTISOL IMMUNOASSAY is JFT.

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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.

K963251CIBA 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 IMMUNOASSAYK962041ACS LH2 IMMUNOASSAY

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Related Devices (Code: JFT)

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.

K242505Elecsys Cortisol IIIRoche DiagnosticsK192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche DiagnosticsK062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.K033731AXSYM CORTISOL ASSAYFujirebio Diagnostics,Inc.K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.

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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