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)

TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD

K-Number: K893913 · 1989-08-21

ApplicantTechnicon Instruments Corp.
Decision Date1989-08-21
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K893913. 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 TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD?

TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K893913.

When did TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD receive FDA 510(k) clearance?

TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893913.

Who is the listed applicant for TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD?

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

What is the FDA product code for TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD?

The FDA product code for TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD 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 Technicon Instruments Corp. 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

View all 157 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 COK882294EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAYSyva Co.

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.

↑