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FDA 510(k)

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING

K-Number: K972772 · 1999-07-13

ApplicantTrek Diagnostic Systems, Inc.
Decision Date1999-07-13
Product CodeMJA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING 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 1999-07-13 under 510(k) number K972772. The device is classified under product code MJA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING?

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING is a medical device that received FDA 510(k) clearance on 1999-07-13. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K972772.

When did ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING receive FDA 510(k) clearance?

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING received FDA 510(k) clearance on 1999-07-13, under 510(k) number K972772.

Who is the listed applicant for ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING?

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 ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING?

The FDA product code for ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING is MJA.

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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.

K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATESK090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESK083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESK081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSK081520SENSITITRE VIZIONK073653SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE

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Related Devices (Code: MJA)

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.

K052323VERSATREK MYCO PZA KITTrek Diagnostic Systems, Inc.K021582BACTEC MGIT 960 PZA KITBecton, Dickinson & COK014123BACTEC MGIT 960 SIRE KITSBecton, Dickinson & COK003062BACTEC MGIT 960 SIR KITSBd Becton Dickinson Vacutainer Systems Preanalytic

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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