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FDA 510(k)

URINE CULTURE KIT

K-Number: K790366 · 1979-04-04

Decision Date1979-04-04
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URINE CULTURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K790366. 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 CULTURE KIT?

URINE CULTURE KIT is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K790366.

When did URINE CULTURE KIT receive FDA 510(k) clearance?

URINE CULTURE KIT received FDA 510(k) clearance on 1979-04-04, under 510(k) number K790366.

Who is the listed applicant for URINE CULTURE KIT?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE CULTURE KIT?

The FDA product code for URINE CULTURE KIT 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.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

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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.

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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