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FDA 510(k)

CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY

K-Number: K951169 · 1995-06-20

ApplicantCiba Corning Diagnostics Corp.
Decision Date1995-06-20
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CIBA CORINING ACS THEOPHYLLINE 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 1995-06-20 under 510(k) number K951169. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY?

CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K951169.

When did CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY receive FDA 510(k) clearance?

CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY received FDA 510(k) clearance on 1995-06-20, under 510(k) number K951169.

Who is the listed applicant for CIBA CORINING ACS THEOPHYLLINE 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 CORINING ACS THEOPHYLLINE IMMUNOASSAY?

The FDA product code for CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY is LGS.

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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: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott LaboratoriesK922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott Laboratories

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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