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FDA 510(k)

CIBA CORNING ACS FOLATE ASSAY

K-Number: K943297 · 1994-12-12

ApplicantCiba Corning Diagnostics Corp.
Decision Date1994-12-12
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS FOLATE 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 1994-12-12 under 510(k) number K943297. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING ACS FOLATE ASSAY?

CIBA CORNING ACS FOLATE ASSAY is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K943297.

When did CIBA CORNING ACS FOLATE ASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS FOLATE ASSAY received FDA 510(k) clearance on 1994-12-12, under 510(k) number K943297.

Who is the listed applicant for CIBA CORNING ACS FOLATE 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 FOLATE ASSAY?

The FDA product code for CIBA CORNING ACS FOLATE ASSAY is CGN.

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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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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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