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FDA 510(k)

BACTEC MGIT 960 SYSTEM

K-Number: K974883 · 1998-05-01

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1998-05-01
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC MGIT 960 SYSTEM 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 1998-05-01 under 510(k) number K974883. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTEC MGIT 960 SYSTEM?

BACTEC MGIT 960 SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K974883.

When did BACTEC MGIT 960 SYSTEM receive FDA 510(k) clearance?

BACTEC MGIT 960 SYSTEM received FDA 510(k) clearance on 1998-05-01, under 510(k) number K974883.

Who is the listed applicant for BACTEC MGIT 960 SYSTEM?

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 BACTEC MGIT 960 SYSTEM?

The FDA product code for BACTEC MGIT 960 SYSTEM is MDB.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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Related Devices (Code: MDB)

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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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