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FDA 510(k)

JUSTONE(TM)

K-Number: K912846 · 1991-08-22

ApplicantSensititre Microbiology A Div. of Radiometer
Decision Date1991-08-22
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JUSTONE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Sensititre Microbiology A Div. of Radiometer. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K912846. 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 JUSTONE(TM)?

JUSTONE(TM) is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Sensititre Microbiology A Div. of Radiometer. The 510(k) number is K912846.

When did JUSTONE(TM) receive FDA 510(k) clearance?

JUSTONE(TM) received FDA 510(k) clearance on 1991-08-22, under 510(k) number K912846.

Who is the listed applicant for JUSTONE(TM)?

The FDA 510(k) record lists Sensititre Microbiology A Div. of Radiometer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUSTONE(TM)?

The FDA product code for JUSTONE(TM) 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 Sensititre Microbiology A Div. of Radiometer 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.

K912778HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATEK912613GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)

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.

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