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FDA 510(k)

CIBA CORNING 400 SYSTEM

K-Number: K961657 · 1996-06-25

ApplicantCiba Corning Diagnostics Corp.
Decision Date1996-06-25
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING 400 SYSTEM 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 1996-06-25 under 510(k) number K961657. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING 400 SYSTEM?

CIBA CORNING 400 SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-25. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K961657.

When did CIBA CORNING 400 SYSTEM receive FDA 510(k) clearance?

CIBA CORNING 400 SYSTEM received FDA 510(k) clearance on 1996-06-25, under 510(k) number K961657.

Who is the listed applicant for CIBA CORNING 400 SYSTEM?

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 400 SYSTEM?

The FDA product code for CIBA CORNING 400 SYSTEM is CHL.

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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, & 4K962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAYK962041ACS LH2 IMMUNOASSAY

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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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