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FDA 510(k)

CIBA CORNING ACS DIGOXIN IMMUNOASSAY

K-Number: K902861 · 1990-09-10

ApplicantCiba Corning Diagnostics Corp.
Decision Date1990-09-10
Product CodeDON
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS DIGOXIN 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 1990-09-10 under 510(k) number K902861. The device is classified under product code DON. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING ACS DIGOXIN IMMUNOASSAY?

CIBA CORNING ACS DIGOXIN IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K902861.

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

CIBA CORNING ACS DIGOXIN IMMUNOASSAY received FDA 510(k) clearance on 1990-09-10, under 510(k) number K902861.

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

The FDA product code for CIBA CORNING ACS DIGOXIN IMMUNOASSAY is DON.

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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: DON)

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.

K881679CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAYCiba Corning Diagnostics Corp.K840461MAGIC 125I DIGOXIN RADIOIMMUNOASSAYCorning Medical & ScientificK830533PHASE II DIGOXIN RADIOIMMUNOASSAY KITMedical & Scientific Designs, Inc.K822053ZETAPHASE-DIGBiological & Diagnostic ProductsK821000ENZYMUNE-TEST DIGOXINIcl ScientificK810296DIGOXIN RIA ASSAYRia Diagnostics

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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