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FDA 510(k)

ACS GENTAMICIN

K-Number: K953020 · 1995-08-02

ApplicantCiba Corning Diagnostics Corp.
Decision Date1995-08-02
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACS GENTAMICIN 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 1995-08-02 under 510(k) number K953020. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS GENTAMICIN?

ACS GENTAMICIN is a medical device that received FDA 510(k) clearance on 1995-08-02. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K953020.

When did ACS GENTAMICIN receive FDA 510(k) clearance?

ACS GENTAMICIN received FDA 510(k) clearance on 1995-08-02, under 510(k) number K953020.

Who is the listed applicant for ACS GENTAMICIN?

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 ACS GENTAMICIN?

The FDA product code for ACS GENTAMICIN is LCD.

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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: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.

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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