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FDA 510(k)

SENSITITRE 18-24HR SUSCEPTIBILITY PLATES

K-Number: K093865 · 2010-02-17

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2010-02-17
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE 18-24HR SUSCEPTIBILITY PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Trek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 2010-02-17 under 510(k) number K093865. 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 18-24HR SUSCEPTIBILITY PLATES?

SENSITITRE 18-24HR SUSCEPTIBILITY PLATES is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K093865.

When did SENSITITRE 18-24HR SUSCEPTIBILITY PLATES receive FDA 510(k) clearance?

SENSITITRE 18-24HR SUSCEPTIBILITY PLATES received FDA 510(k) clearance on 2010-02-17, under 510(k) number K093865.

Who is the listed applicant for SENSITITRE 18-24HR SUSCEPTIBILITY PLATES?

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

What is the FDA product code for SENSITITRE 18-24HR SUSCEPTIBILITY PLATES?

The FDA product code for SENSITITRE 18-24HR SUSCEPTIBILITY PLATES is JWY.

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Other records listing Trek Diagnostic Systems, 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.

K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESK083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESK081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSK081520SENSITITRE VIZIONK073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATEK073558SENSITITRE 18-24 SUSCEPTIBILITY PLATE

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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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