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FDA 510(k)

MULTIGENT GENTAMICIN

K-Number: K060709 · 2006-06-15

ApplicantSeradyn, Inc.
Decision Date2006-06-15
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MULTIGENT GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2006-06-15 under 510(k) number K060709. 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 MULTIGENT GENTAMICIN?

MULTIGENT GENTAMICIN is a medical device that received FDA 510(k) clearance on 2006-06-15. The listed applicant is Seradyn, Inc.. The 510(k) number is K060709.

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

MULTIGENT GENTAMICIN received FDA 510(k) clearance on 2006-06-15, under 510(k) number K060709.

Who is the listed applicant for MULTIGENT GENTAMICIN?

The FDA 510(k) record lists Seradyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIGENT GENTAMICIN?

The FDA product code for MULTIGENT GENTAMICIN is LCD.

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Other records listing Seradyn, Inc. 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSK051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

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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 LaboratoriesK042479VITROS 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.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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