FDA 510(k)

BACTEC RESIN CULTURE MED. 16A

K-Number: K812315 · 1981-11-10

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1981-11-10

Product CodeMDB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BACTEC RESIN CULTURE MED. 16A 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 1981-11-10 under 510(k) number K812315. 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 RESIN CULTURE MED. 16A?

BACTEC RESIN CULTURE MED. 16A is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K812315.

When did BACTEC RESIN CULTURE MED. 16A receive FDA 510(k) clearance?

BACTEC RESIN CULTURE MED. 16A received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812315.

Who is the listed applicant for BACTEC RESIN CULTURE MED. 16A?

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 RESIN CULTURE MED. 16A?

The FDA product code for BACTEC RESIN CULTURE MED. 16A is 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.