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FDA 510(k)

SUSCEPTIBILITY TEST PANEL

K-Number: K004045 · 2001-03-06

ApplicantTrek Diagnostic Systems, Inc.
Decision Date2001-03-06
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SUSCEPTIBILITY TEST PANEL 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 2001-03-06 under 510(k) number K004045. 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 SUSCEPTIBILITY TEST PANEL?

SUSCEPTIBILITY TEST PANEL is a medical device that received FDA 510(k) clearance on 2001-03-06. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K004045.

When did SUSCEPTIBILITY TEST PANEL receive FDA 510(k) clearance?

SUSCEPTIBILITY TEST PANEL received FDA 510(k) clearance on 2001-03-06, under 510(k) number K004045.

Who is the listed applicant for SUSCEPTIBILITY TEST PANEL?

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 SUSCEPTIBILITY TEST PANEL?

The FDA product code for SUSCEPTIBILITY TEST PANEL 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 ANTIMICROBICSK081520SENSITITRE VIZIONK073653SENSITITRE 18 - 24 HOUR 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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