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FDA 510(k)

BACTEC MGIT 960 SIRE KITS

K-Number: K014123 · 2002-04-19

ApplicantBecton, Dickinson & CO
Decision Date2002-04-19
Product CodeMJA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC MGIT 960 SIRE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2002-04-19 under 510(k) number K014123. The device is classified under product code MJA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTEC MGIT 960 SIRE KITS?

BACTEC MGIT 960 SIRE KITS is a medical device that received FDA 510(k) clearance on 2002-04-19. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K014123.

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

BACTEC MGIT 960 SIRE KITS received FDA 510(k) clearance on 2002-04-19, under 510(k) number K014123.

Who is the listed applicant for BACTEC MGIT 960 SIRE KITS?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BACTEC MGIT 960 SIRE KITS?

The FDA product code for BACTEC MGIT 960 SIRE KITS is MJA.

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Related Devices (Code: MJA)

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K052323VERSATREK MYCO PZA KITTrek Diagnostic Systems, Inc.K021582BACTEC MGIT 960 PZA KITBecton, Dickinson & COK003062BACTEC MGIT 960 SIR KITSBd Becton Dickinson Vacutainer Systems PreanalyticK972772ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTINGTrek Diagnostic Systems, 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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