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)

IN-VITRO TEST DETERMINATION OF TOBRAMYCIN

K-Number: K854184 · 1985-12-04

ApplicantClinical Data, Inc.
Decision Date1985-12-04
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IN-VITRO TEST DETERMINATION OF TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1985-12-04 under 510(k) number K854184. The device is classified under product code KLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-VITRO TEST DETERMINATION OF TOBRAMYCIN?

IN-VITRO TEST DETERMINATION OF TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 1985-12-04. The listed applicant is Clinical Data, Inc.. The 510(k) number is K854184.

When did IN-VITRO TEST DETERMINATION OF TOBRAMYCIN receive FDA 510(k) clearance?

IN-VITRO TEST DETERMINATION OF TOBRAMYCIN received FDA 510(k) clearance on 1985-12-04, under 510(k) number K854184.

Who is the listed applicant for IN-VITRO TEST DETERMINATION OF TOBRAMYCIN?

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

What is the FDA product code for IN-VITRO TEST DETERMINATION OF TOBRAMYCIN?

The FDA product code for IN-VITRO TEST DETERMINATION OF TOBRAMYCIN is KLB.

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 Clinical Data, 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR

View all 36 devices →

Related Devices (Code: KLB)

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.

K060853ONLINE TDM TOBRAMYCINRoche Diagnostics Corp.K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)Diagnostic Products Corp.K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.K904304DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHODE.I. Dupont DE Nemours & Co., Inc.K903192IL TOBRAMYCIN ASSAYInstrumentation Laboratory COK893913TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODTechnicon Instruments 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.

↑