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FDA 510(k)

VERSATREK MYCO PZA KIT

K-Number: K052323 · 2006-01-19

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2006-01-19
Product CodeMJA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VERSATREK MYCO PZA KIT 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 2006-01-19 under 510(k) number K052323. 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 VERSATREK MYCO PZA KIT?

VERSATREK MYCO PZA KIT is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K052323.

When did VERSATREK MYCO PZA KIT receive FDA 510(k) clearance?

VERSATREK MYCO PZA KIT received FDA 510(k) clearance on 2006-01-19, under 510(k) number K052323.

Who is the listed applicant for VERSATREK MYCO PZA KIT?

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 VERSATREK MYCO PZA KIT?

The FDA product code for VERSATREK MYCO PZA KIT 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.

K021582BACTEC MGIT 960 PZA KITBecton, Dickinson & COK014123BACTEC MGIT 960 SIRE KITSBecton, Dickinson & COK003062BACTEC MGIT 960 SIR KITSBd Becton Dickinson Vacutainer Systems PreanalyticK972772ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTINGTrek Diagnostic Systems, Inc.

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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