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)

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP

K-Number: K944753 · 1995-02-24

ApplicantRadiometer America, Inc.
Decision Date1995-02-24
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K944753. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP?

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Radiometer America, Inc.. The 510(k) number is K944753.

When did SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP receive FDA 510(k) clearance?

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP received FDA 510(k) clearance on 1995-02-24, under 510(k) number K944753.

Who is the listed applicant for SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP?

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

What is the FDA product code for SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP?

The FDA product code for SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP is JWY.

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 Radiometer America, 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.

K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitK992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULEK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

View all 50 devices →

Related Devices (Code: JWY)

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.

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

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.

↑