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FDA 510(k)

CIBA CORNING ACS;180 DPD ASSAY

K-Number: K963251 · 1996-10-15

ApplicantCiba Corning Diagnostics Corp.
Decision Date1996-10-15
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS;180 DPD ASSAY 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 1996-10-15 under 510(k) number K963251. The device is classified under product code JMM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING ACS;180 DPD ASSAY?

CIBA CORNING ACS;180 DPD ASSAY is a medical device that received FDA 510(k) clearance on 1996-10-15. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K963251.

When did CIBA CORNING ACS;180 DPD ASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS;180 DPD ASSAY received FDA 510(k) clearance on 1996-10-15, under 510(k) number K963251.

Who is the listed applicant for CIBA CORNING ACS;180 DPD ASSAY?

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;180 DPD ASSAY?

The FDA product code for CIBA CORNING ACS;180 DPD ASSAY is JMM.

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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.

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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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