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FDA 510(k)

BACTEC NR-730 BACTERIAL DETECTION SYSTEM

K-Number: K853011 · 1985-07-30

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1985-07-30
Product CodeJTA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC NR-730 BACTERIAL DETECTION 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 1985-07-30 under 510(k) number K853011. The device is classified under product code JTA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTEC NR-730 BACTERIAL DETECTION SYSTEM?

BACTEC NR-730 BACTERIAL DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K853011.

When did BACTEC NR-730 BACTERIAL DETECTION SYSTEM receive FDA 510(k) clearance?

BACTEC NR-730 BACTERIAL DETECTION SYSTEM received FDA 510(k) clearance on 1985-07-30, under 510(k) number K853011.

Who is the listed applicant for BACTEC NR-730 BACTERIAL DETECTION 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 NR-730 BACTERIAL DETECTION SYSTEM?

The FDA product code for BACTEC NR-730 BACTERIAL DETECTION SYSTEM is JTA.

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Related Devices (Code: JTA)

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.

K954923BACTEC FUNGAL MEDIUMBecton Dickinson Diagnostic Instrument SystemsK910835BACTEC NR-860Bd Becton Dickinson Vacutainer Systems PreanalyticK865021BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK842874RADIOMETRIC BLOOD CULTURE VIALS, AEROBEAmerican Micro ScanK842279BECTEC NR-660 BACTERIAL DETECT SYSBd Becton Dickinson Vacutainer Systems PreanalyticK833917BAC-T-SCREENMarion 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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