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FDA 510(k)

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD

K-Number: K904305 · 1990-10-15

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1990-10-15
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1990-10-15 under 510(k) number K904305. 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 DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD?

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD is a medical device that received FDA 510(k) clearance on 1990-10-15. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K904305.

When did DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD receive FDA 510(k) clearance?

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD received FDA 510(k) clearance on 1990-10-15, under 510(k) number K904305.

Who is the listed applicant for DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD?

The FDA product code for DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD is LCD.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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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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