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FDA 510(k)

QMS GENTAMICIN ASSAY

K-Number: K940376 · 1994-06-02

ApplicantSeradyn, Inc.
Decision Date1994-06-02
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS GENTAMICIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K940376. 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 QMS GENTAMICIN ASSAY?

QMS GENTAMICIN ASSAY is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Seradyn, Inc.. The 510(k) number is K940376.

When did QMS GENTAMICIN ASSAY receive FDA 510(k) clearance?

QMS GENTAMICIN ASSAY received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940376.

Who is the listed applicant for QMS GENTAMICIN ASSAY?

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 QMS GENTAMICIN ASSAY?

The FDA product code for QMS GENTAMICIN ASSAY 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 TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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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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