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FDA 510(k)

THREE LEVEL CONTROL SERA

K-Number: K810459 · 1981-08-03

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1981-08-03
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THREE LEVEL CONTROL SERA 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 1981-08-03 under 510(k) number K810459. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THREE LEVEL CONTROL SERA?

THREE LEVEL CONTROL SERA is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K810459.

When did THREE LEVEL CONTROL SERA receive FDA 510(k) clearance?

THREE LEVEL CONTROL SERA received FDA 510(k) clearance on 1981-08-03, under 510(k) number K810459.

Who is the listed applicant for THREE LEVEL CONTROL SERA?

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 THREE LEVEL CONTROL SERA?

The FDA product code for THREE LEVEL CONTROL SERA is DHX.

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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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