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FDA 510(k)

ROCHE ONLINE GENTAMICIN

K-Number: K020704 · 2002-07-12

ApplicantRoche Diagnostics Corp.
Decision Date2002-07-12
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ONLINE GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K020704. 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 ROCHE ONLINE GENTAMICIN?

ROCHE ONLINE GENTAMICIN is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K020704.

When did ROCHE ONLINE GENTAMICIN receive FDA 510(k) clearance?

ROCHE ONLINE GENTAMICIN received FDA 510(k) clearance on 2002-07-12, under 510(k) number K020704.

Who is the listed applicant for ROCHE ONLINE GENTAMICIN?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE ONLINE GENTAMICIN?

The FDA product code for ROCHE ONLINE GENTAMICIN is LCD.

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Other records listing Roche Diagnostics Corp. 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.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.K012311IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)Diagnostic Products Corp.

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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