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FDA 510(k)

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

K-Number: K983244 · 1998-11-30

ApplicantTrek Diagnostic Systems, Inc.
Decision Date1998-11-30
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) 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 1998-11-30 under 510(k) number K983244. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)?

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Trek Diagnostic Systems, Inc.. The 510(k) number is K983244.

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

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) received FDA 510(k) clearance on 1998-11-30, under 510(k) number K983244.

Who is the listed applicant for SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)?

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 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)?

The FDA product code for SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) is JTW.

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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: JTW)

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.

K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock TechnologiesK061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, 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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