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FDA 510(k)

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM

K-Number: K013819 · 2002-02-28

ApplicantSierra Diagnostic, LLC
Decision Date2002-02-28
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Diagnostic, LLC. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K013819. 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 URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM?

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Sierra Diagnostic, LLC. The 510(k) number is K013819.

When did URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM receive FDA 510(k) clearance?

URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM received FDA 510(k) clearance on 2002-02-28, under 510(k) number K013819.

Who is the listed applicant for URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM?

The FDA 510(k) record lists Sierra Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM?

The FDA product code for URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM is JTW.

Related Clinical Trials

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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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.K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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