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)

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

K-Number: K001547 · 2000-08-07

ApplicantAb Biodisk
Decision Date2000-08-07
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2000-08-07 under 510(k) number K001547. 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 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP?

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP is a medical device that received FDA 510(k) clearance on 2000-08-07. The listed applicant is Ab Biodisk. The 510(k) number is K001547.

When did ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP receive FDA 510(k) clearance?

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP received FDA 510(k) clearance on 2000-08-07, under 510(k) number K001547.

Who is the listed applicant for ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP?

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

What is the FDA product code for ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP?

The FDA product code for ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP 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 Ab Biodisk 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.

K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLK052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAK042392DAPTOMYCINK042390ETEST FOR GEMIFLOXACINK040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGK021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

View all 64 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.

↑