Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QMS AMIKACIN REAGENTS

K-Number: K052815 · 2005-11-01

ApplicantSeradyn, Inc.
Decision Date2005-11-01
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS AMIKACIN REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2005-11-01 under 510(k) number K052815. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS AMIKACIN REAGENTS?

QMS AMIKACIN REAGENTS is a medical device that received FDA 510(k) clearance on 2005-11-01. The listed applicant is Seradyn, Inc.. The 510(k) number is K052815.

When did QMS AMIKACIN REAGENTS receive FDA 510(k) clearance?

QMS AMIKACIN REAGENTS received FDA 510(k) clearance on 2005-11-01, under 510(k) number K052815.

Who is the listed applicant for QMS AMIKACIN REAGENTS?

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 AMIKACIN REAGENTS?

The FDA product code for QMS AMIKACIN REAGENTS is KLQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 28 devices →

Related Devices (Code: KLQ)

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.

K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, Inc.K843211AMIKACIN ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., Inc.

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.

↑