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FDA 510(k)

SENSITITRE VIZION

K-Number: K081520 · 2008-10-24

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2008-10-24
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE VIZION 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 2008-10-24 under 510(k) number K081520. 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 VIZION?

SENSITITRE VIZION is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K081520.

When did SENSITITRE VIZION receive FDA 510(k) clearance?

SENSITITRE VIZION received FDA 510(k) clearance on 2008-10-24, under 510(k) number K081520.

Who is the listed applicant for SENSITITRE VIZION?

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 VIZION?

The FDA product code for SENSITITRE VIZION 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.

K093865SENSITITRE 18-24HR SUSCEPTIBILITY PLATESK090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESK083606SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATESK081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSK073653SENSITITRE 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.

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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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